Maquet Cardiovascular Us Sales, Llc Recalls
Showing 1-20 of 42 recalls
HLS Set Advanced Model Name: BEQ-HLS 5050 USA; HLS Set Advanced 5.0, Product Code/Part Number: 70105.2797 - Product Usage: These devices are used with the CARDIOHELP system in order to provide extracorporeal circulation for cardiac support and/or pulmonary support.
The HLS Set Advanced (disposable for Cardiohelp) is being recalled due to breaches in the product's sterility barrier.
Actions to be taken: Please examine your inventory immediately to determine if you have any of the affected HLS Set Advanced with the product codes and lot numbers listed on page 1 of this notice and acknowledge that you have received this notification by following the instructions below. If an affected device is already in use, please continue using according to normal practices. Should you have any un-used and un-expired affected product you are eligible to return the affected product for credit. Please contact Getinge Customer Service at (888) 9GETUSA / (800) 943-8872 (press option 2) between the hours of 8:00 a.m. and 6:00 p.m. Eastern Standard Time to request a return authorization (RMA) and shipping instructions to return any affected product. Pack the product to be returned with the appropriate return documents and, using the shipping instructions provided, arrange for pickup with the designated delivery service provider. Please also enter the affected lot numbers, quantity and RMA number provided by Customer Service in the spaces provided on the Medical Device Recall Expansion - Removal Response Form on Page 4 of this letter, if you are returning products to Maquet/Getinge. Please complete and sign the attached MEDICAL DEVICE RECALL Removal RESPONSE FORM (page 4) to acknowledge that you have received this notification. Return the completed form to Maquet/Getinge by e-mailing a scanned copy to acthlsset2020.us@getinge.com or by faxing the form to (800) 866-5751. This voluntary recall only affects the products listed on page 1; no other products are affected by this voluntary recall. Adverse reactions or quality problems experienced with the use of this product may be reported to the FDAs MedWatch Adverse Event Reporting program either online, by regular mail or by fax using the following: " Online: www.accessdata.fda.gov/scripts/medwatch/ " Regular Mail: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088
Getinge 86-Series-Medical Washer-Disinfector Part Number: S-86662003 Product Usage: Usage: The Getinge 86 Series Medical Washer-Disinfector is designed for use in healthcare facilities and laboratories where reusable items such as instruments, utensils, anesthesia sets, and glassware are handled for decontamination purposes.
Possibility that inlet pump hose of the Washer Disinfector Getinge 86-Series (S-8666, S-8668) might collapse during use result in low water pressure within the circulation system and, in the worst case scenario, can result in the contents of the Washer Disinfector not being cleaned properly after finished process.
Getinge issued a An Urgent Medical Device Correction to U.S. consignees on 5/20/19 via FedEx 2 day Delivery with Signature Proof of Delivery (SPOD). Letter provides identification of the issue, health risk and action to take: examine your inventory immediately, Until the required correction has been completed, take the following precautions detailed in the User Manual: Do not operate the machine unattended. Always inspect the processed goods after a wash cycle. Contact a Getinge Service person if either of these are noticed: o If the washer starts to sound different than usual during a wash cycle, abort the process and call your service person.o Goods are not cleaned after the process is finished. Getinge Service person will contact the person you listed on the Customer Response Form to schedule service for an update of your device, free of charge. You can also arrange a visit by a Getingetrained or authorized service technician by calling Getinge Customer Support at 18009509912 (select option 1). Customer Service hours: 8:00 AM to 5:00 PM (EST) Monday to Friday
Getinge 46-Series Washer Disinfector Model # 46-4, Part Number:46-4-502 Product Usage: Used in facilities such as Central Sterile Supply Departments, next to the Operating Room, in dental clinics or hospital wards to clean, thermally or chemically disinfect and dry surgical goods.
Due to a missing water intake for Deionized water on the Getinge 46-Series Washer Disinfector. There were no valve, hose, or clamps for this option included with the device therefore the units could not be properly installed. There have been no adverse events reported resulting in serious illness or injuries.
Getinge issued an Urgent Medical Device Recall Correction letter to U.S. consignees via FedEx Priority Overnight delivery with signature proof of delivery on January 16, 2020. Letter provides identification of the issue, health risk and action to take. Customers were advised to examine your inventory immediately, complete and sign the MEDICAL DEVICE RECALL - RESPONSE FORM to acknowledge that you have received this notification, return the completed form to Getinge Disinfection AB by e-mailing a scanned copy to swic46-series.us@getinge.com or by faxing the form to 1-800-574-5051. Should you have one or more Getinge 46-Series Washer Disinfectors (models 46-4-502 and 46-4-503) you will be contacted by a Getinge Service Representative to schedule on-site service of your device, free of charge, by a Getinge Service Representative. You can also arrange a visit by a Getinge trained or authorized service technician by contacting Getinge Customer Technical Support at (888) 9438872 (select option 1, then option 2), Monday through Friday, between the hours of 8:00 a.m. and 6:00 p.m. (Eastern Time Zone). If you are a distributor who has shipped any affected products to customers, please forward this document to their attention for appropriate action.
Getinge 88-Series-washer disinfectors intended for cleaning, disinfection and drying Model Number: 88-5 Part Number: 88-103; 88-203
Potential leakage that may occur due to ruptured spot welds in the chamber, could generate a situation for the user such as risk for slipping or infection from contaminated water
Getinge issued letter dated 2/10/20 Letters via FedEx Priority Overnight Delivery with Signature Proof of Delivery (SPOD).Letter states reason for recall, health risk and action to take: Please examine your inventory immediately to determine if you have any affected Getinge 88-Series Washer Disinfectors (models 88-5) indicated by this notice; Once you have located the affected device, check to see if it is leaking underneath the machine or near the machines foot print. If the machine is leaking, call for Service Technician and plan for service. You can continue to use the machine but we recommend posting a sign for precaution. Units where leakage is observed will be prioritized in order to repair the unit. If your unit is found to be leaking due to this issue, it will be repaired free of charged. You can also arrange a visit by a Getinge trained or authorized service technician by contacting Getinge Customer Technical Support at (888) 9438872 (select option 1, then option 2), Monday through Friday, between the hours of 8:00 a.m. and 6:00 p.m. (Eastern Time Zone). Complete and sign the attached MEDICAL DEVICE RECALL - RESPONSE FORM (page 4) to acknowledge that you have received this notification.
Maquet VOLISTA StandOP Surgical Lights- Product Code: ARD568811901 Model: VLT600SF AIM STP
Potential that the coating of the light head forks on the VOLISTA Surgical Lights may crack, posing the risk of particles falling into the surgical field during surgery that may result in patient infection
Getinge/Maquet SAS issued on 5/28/19 Urgent Medical Correction letter via FedEx 2 day Delivery with Signature Proof of Delivery (SPOD). Letter provides identification of issue, health risk and action to take: Before using the VOLISTA StandOP, please inspect the forks and check if cracks on the coating are visible as instructed in the VOLISTA StandOP manual; If a coating crack is detected, please STOP USING the VOLISTA StandOP and contact your Getinge representative. Complete and sign the attached MEDICAL DEVICE CORRECTION RESPONSE FORM . Return the completed form to Maquet/Getinge by e-mailing a scanned copy to VOLISTAFork2019@getinge.com or by faxing the form to 1-707-202-7275;A Getinge Sales or Service representative will contact you to schedule inspection and correction if necessary of the VOLISTA StandOP SURGICAL LIGHTS at your facility. For technical questions, contact Technical Support Department at 1-888-627-8383 (press option 3 then option 1), Monday through Friday, between the hours of 8:00 a.m. and 6:00 p.m. EST. ***Updated 3/30/2020*** On March 30, 2020, the firm sent an new letter to customers, informing them of an update to the corrective actions previously communicated. The firm has developed an interim solution for affected devices. The solution consists of a validated adhesive strip that is resistant to mechanical stresses and compatible with typical chemical agents used in the operating rooms. The solution allows customers to continue using their lights until their defective forks are replaced. The interim solution will be applied by a Getinge representative. A Getinge Sales or Service representative will contact customers to schedule inspection and correction (if necessary) of affected devices at each facility. If your site has already been contacted to schedule an inspection, the work above will be performed during that scheduled visit.
Blood Monitoring Unit (BMU 40), model no. 701040852 - Product Usage: is to monitor blood parameters during cardiopulmonary bypass (CPB) or similar procedures with extracorporeal circulation, which require continuous monitoring of the arterial and/or venous blood parameters: partial pressure of oxygen (pO2), temperature (TArt and TVen), oxygen saturation (SO2), hemoglobin (Hb) and hematocrit (Hct).
The Printed Circuit Board Assembly (PCBA) are not in compliance with the IEC standard (60601 1, third edition). The BMU 40 units affected by this recall were designed with a short creepage distance of 1.8 mm between the two distinct and proximal areas on the printed circuit board (PCB) where as the standard requires a creepage distance of 4 mm.
On September 30, 2020, the firm issued an Urgent Medical Device Recall letter to all affected consignees. Customers were informed that the printed circuit board assembly for the affected devices are not in compliance with the IEC standard. Actions to be taken by the user: -Please examine your inventory immediately to determine if you have a BMU 40 with any of the affected serial numbers. The serial number tag is on the rear of the device. -Your facility may continue to use the BMU 40 pending replacement of the PCBA Connector, by adhering to the following recommendations: Use the equipotential bonding connector on the rear of the BMU 40 Properly ground any accessory equipment connect to the BMU 40 Do not connect external devices to the BMU 40 serial ports (Com 1 /Com 2) with an operational/ communication voltage exceeding 25 VDC. See Figure 2 below. Use standard PPE (e.g. nitrile gloves) while operating the BMU 40 Follow IFU recommendations including avoid simultaneous contact with the patient and device. Getinge has developed a correction that will be available in Q1 2021. Should you require a loaner unit while service is being performed on your affected unit, Getinge will provide you a loaner unit when available, prior to the return of your affected unit to Getinge. Please complete and sign the included MEDICAL DEVICE CORRECTION RESPONSE FORM Getinge has developed a correction that will be available in Q1 2021. Once available, Getinge will contact the person you listed on the Response Form to arrange shipment of the affected BMU 40 unit to the Getinge Service Center in New Jersey. The BMU 40 will be returned to your facility upon completion of the correction. You may also call Getinge Tech Support at (888) 9GETUSA / (888) 9438872 Option 4,2,1 between the hours of 8:00 a.m. and 6:00 p.m. Eastern Standard Time.
Yuno Mobile Operating Table - Product Usage: Intended for support and position the patient immediately before, during and after surgical interventions as well as for examination and treatment. Part 143301F0 (US) Part 143301B0 (OUS)
Plastic socket of the IEC 60320-1 socket pulled out of the metal cage and electronic parts exposed; where the socket was pulled out and main cable is still connected to the main socket (power source), there is a risk that a user or third person may suffer an electric shock when coming in contact with the exposed electronic components
Getinge issued Urgent Medical Device Recall on September 24, 2020, via FedEx 2 day delivery to US consignees. The letter states reason for recall, health risk and action to take: Per the IFU, section 9.1 (Yuno) and 8.1 (Yuno II), a visual and functional check is required to be performed by a trained person before operation. Follow the instructions in section 4.2.3.1of the Yuno and Yuno II IFU regarding connecting and disconnecting from the mains socket (power source). If the plastic socket of the cold-device plug is pulled out, do not try to put it back into the housing and if there are any exposed electronic components, do not touch them. Disconnect/detach the cable from the main socket, call your in-house technical service and arrange the repair of the table. Per IFU section 9.4 (Yuno) and 8.5 (Yuno II), a defective product may not be used and may not be repaired by yourself. A Getinge Service representative will contact you to schedule the correction. This work will be done at no cost to your facility Please complete and sign the attached URGENT MEDICAL DEVICE RECALL CORRECTION RESPONSE FORM (page 4) to acknowledge that you have received this notification. Return the completed form to Maquet/Getinge by e-mailing a scanned copy to MEERA2019@getinge.com or by faxing the form to 1-973-807-9205
Holder HKHZ 19 for use with Quadrox-i and Quadrox-iD Neonatal / Pediatric Oxygenators, Model Number: 701047495 - Product Usage: The Holder HKHZ 19 is an accessory to QUADROX i and QUADROX iD Neonatal / Pediatric oxygenator and is being used as a single holder for QUADROX i and QUADROX iD Neonatal / Pediatric Oxygenator and can also be used in combination with the holder's arm (016061) to use in cardiopulmonary bypass procedures (CPB) in a pediatric patient population.
Removal for a specific lot, lot number 70128207, of Holder HKHZ 19 for use with QUADROX iD Pediatric Oxygenator. The Holder may not always snap and securely hold the oxygenator as intended.
Getinge sent a customer letter dated July 2020 instructing customers to remove the affected products from areas of use and return the product(s) to Getinge following the provided instructions.
GETINGE MEERA MOBILE OPERATING TABLE: (1) Part 720001B2 (2) Part 720001B0 (3) Part 720001F2 (4) Part 720001F0 (5) Part 710001B2 (6) Part 710001B0 (7) Part 710001F0 Product Usage: The Meera Mobile Operating Table is designed to support and position the patient immediately before, during and after surgical interventions as well as for examination and treatment.
User may suffer an electric shock when coming in contact with the exposed electronic components
Maquet /Getinge issued URGENT MEDICAL DEVICE CORRECTION Notice on 5/6/19, identified issued, health risk and action to take: Per the IFU, section 8.1, a visual and functional check is required to be performed by a trained person before operation; If the plastic socket of the cold-device plug is pulled out do not try to put it back into the housing and if there are any exposed electronic components: do not touch them. Call your in-house technical service and arrange the repair of the table. Per IFU section 8.5 a defective product may not be used and may not be repaired by yourself. Complete/sign and return the MEDICAL DEVICE RECALL CORRECTION RESPONSE FORM. Questions contact Technical Support Department at 1-888-627-8383 (press option 3 then option 1), Monday through Friday, between the hours of 8:00 a.m. and 6:00 p.m. EST. Expanded Recall: Maquet/Getinge issued letters on 9/24/20 to consignees via FedEx 2 day Delivery with Signature Proof of Delivery (SPOD).
Avalon Elite Vascular Access Kit, Model No. 70106.3540, UDI 04037691831039
A lot of Avalon Elite Vascular Access Kits (VAK) are being recalled due to a material mix-up with the needle portion of the kit; 81 of 255 kits were assembled with an incorrect Arterial Access Needle instead of a Multi-Purpose Procedure Needle.
On February 20, 2020, the recalling firm notified affected customers via Urgent Medical Device Recall letters sent through FedEx. Customers were informed of the material mix-up with the needle portion of the kit. Customers were instructed to immediately examine their inventory to determine if they have any of the affected lot. If so, please remove the kits from areas of use and return the product to Getinge following the instructions in the letter. Unused and unexpired affected product that is returned to Getinge is eligible for full credit.
Maquet/Getinge Rotaflow System Console US (115 V / 60 Hz) - Product Usage: Instructions for Use - Centrifugal Pump System is a device that uses a method other than revolving rollers to pump the blood through an extracorporeal circuit Material Number: 701043292
Instruction For Use (IFU) references incorrect serial number of 90437000. It should state This document applies to ROTAFLOW Consoles as of serial number 94175452 affected by the implementation of the new IEC standard 60601 1 2, 4th edition
Maquet/Getinge issued Urgent Medical Device Correction letter dated August 7, 2020, issued via FedEx 2 day delivery. Letter states reason for recall, health risk and action take: Please examine your inventory immediately to determine if you have a Rotaflow System with a serial number of 94175452 or greater. The serial number tag is on the back of the device (see image below). Please contact your Getinge representative or email IFUrotaflowsystem.cp@getinge.com to request 1 (one) revised IFU/(s). Please supply a mailing address, contact person and phone number on page 4. Please complete and return the form (page 4) to acknowledge this recall by emailing a scanned copy to IFUrotaflowsystem.cp@getinge.com or by faxing the form to 18664771833. A revised IFU will be shipped to you as quickly as possible. In the mantime, please attach a copy of this letter to each copy of the affected IFU. Once you receive the revised IFU, please dispose of the old IFU with the incorrect serial number reference. Qquestions, telephone number +1 973 709 7412 or through email at Rachana.Patel@getinge.com.
Maquet Cardiopulmonary (MCP)/Getinge HLS Set Advanced 7.0. Model Number BEQ-HLS-7050 USA, Part Number 701052794
The sets are configured with quick connectors that have been assembled in reverse on the arterial and venous lines, resulting in blue (venous) to red (arterial) and red (arterial) to blue (venous) connections. Due to this incorrect assembly, the sets cannot be primed from the reservoir prior to use, and the device may not function as intended.
Urgent Medical Device Recall - Removal notification letters dated 7/11/19 were sent to customers.
Maquet Cardiopulmonary (MCP)/Getinge ROTAFLOW Drive, Model Number 701022161. The device is a component of the ROTAFLOW System Console.
A loose ODU plug / Coaxial cable connection may result in fluctuating flow values on the Console.
An Urgent Medical Device Recall notification letter dated 12/3/19 was sent to customers. If your affected RFD unit is in clinical use, switch to RPM mode. Using hospital patient management protocols and physician judgement, perform the following steps: 1. Check your inventory for an unaffected RFD unit . If an unaffected RFD unit is available, it should be at the clinicians discretion to transfer the patient from the affected unit to the unaffected unit. 2. If an unaffected RFD unit is unavailable or if temporary interruption of extracorporeal blood flow is not possible check the following options: a. Please check your inventory for an independent external flow measurement system to measure the actual flow. Only use a reliable external flow measurement that is gauged and zeroed. Use that measurement system in conjunction with the RPM mode. If necessary adjust the RPM according to the flow reading as obtained with the independent external flow measurement system. A continuous control of the patient vital signs monitoring is indicated. If the the Bubble Sensor intervention is already active, leave the setting in place. b. In case no external flow measurement system is available stay on RPM mode and continuously control vital signs monitoring. It is indicated to closely monitor the blood gases of the respective patient. The assessment of the vital sign monitoring and the blood gas analysis in conjunction with the indicated pump speed (RPM) is required. If the the Bubble Sensor intervention is already active, leave the setting in place. 3. When treatment of patient is completed, remove your affected RFD unit from use and follow the Actions to be Taken for return and repair below. If your affected RFD unit is not in clinical use, remove your affected RFD unit and follow the Actions to be Taken for return and repair below. Actions to be taken 1. Our records indicate that you have received a Rotaflow Drive Unit with a serial number that is affected by this
QUADROX-i Neonatal without integrated arterial filter and VHK 11000 (VKMO 10000-USA#QUADROX-i Neo.+Reservoir), Part Number 701055120 The membrane oxygenator QUADROXi Neonatal is intended for use in extracorporeal circulation during cardiopulmonary bypass in cardiac surgery.
There is a potential for blood leakage at the blood inlet connector when using the reducing screw adapter 1/4 x 3/16 that may result in clinically relevant loss of prime before patient connection or blood loss during patient connection.
The firm, GETTINGE, sent an "URGENT MEDICAL DEVICE RECALL" notification letters dated 10/25/18 to customers. The letters described the product, problem, and actions to be taken. The customers were instructed to do the following: -Please immediately examine your inventory to determine if you have any of the QUAD ROX-i Neonatal Oxygenator with the product codes/lot numbers listed in this notice. -If you wish to use the product, please remove and do not use the enclosed reducing screw adapter 1/4" x 3/16" (Ref. No. 70104.8593). -If you do not wish to use the product as packaged, please contact Maquet/Ge tinge Customer Support at +l (888) 627-8383 (press option 2, then option 2), Monday through Friday, between the hours of 8:00 a.m. and 6:00 p.m. (Eastern Time Zone) to obtain instructions on returning the affected product for a full credit. Please note that this product is no longer being offered in the United States, and therefore product replacement is not available. -Please complete and sign the attached MEDICAL DEVICE RECALL- RESPONSE FORM (page 4) to acknowledge that you have received this notification. Return the completed form to Maquet/Ge tinge by e-mailing a scanned copy to neoguadroxi2018@getinge.com or by f axing the form to +l (800) 859-8371. If you are a distributor who has shipped any affected products to customers, please forward this document to their attention for appropriate action. If you have any questions, please contact your Maquet Cardiopulmonary /Ge tinge representative or call the Maquet Cardiopulmonary /Ge tinge Customer Support at +l (888) 627-8383 (press option 2, then option 2), Monday through Friday, between the hours of 8:00 a.m. and 6:00 p.m. (Eastern Time Zone).
Cardiohelp Emergency Drive, Part No. 70104.8002 Product Usage: The Cardiohelp Emergency Drive is used in emergencies to manually drive the disposable if the Cardiohelp-i fails.
Upon servicing the gearwheel in the Emergency Drive the gearwheel may have been re-assembled incorrectly, leading to the inadequate operation of the Emergency Drive.
Maquet has issued an Urgent Medical Device Recall dated February 26, 2019 to affected customers. The letter identified the affected product, problem and actions to be taken. Customers were informed that their Emergency Drives had already been inspected and replaced with a loaner Emergency Drive if found to be affected. Affected E-Drives were returned to Getinge for servicing. Upon servicing, a service technician will return the Emergency Drive to your facility. Customers were asked to complete and sign the customer response form to acknowledge receipt of the notification. If you have any questions, please contact your Maquet Cardiopulmonary (MCP)/Getinge representative or call the Maquet Cardiopulmonary (MCP)/Getinge Customer Support at +1 (888) 627-8383 (press option 2, then option 2), Monday through Friday, between the hours of 8:00 a.m. and 6:00 p.m. (Eastern Time Zone).
QUADROX-i oxygenators Custom tubing packs for the oxygenator
Maquet Cardiopulmonary (MCP) is conducting a voluntary recall based on the potential risk of exposure to endotoxin for various products.
The firm, Maquet Inc., sent an "URGENT MEDICAL DEVICE RECALL" Letter/Response Form dated 2/23/2016 via Fed Ex to their customers. The letter describes the product, problem and actions to be taken. The customers were instructed to review the list to determine if you have the affected products; monitor patients for signs; monitor and treat signs according to your protocols and clinical judgments; support shock symptoms and maintain circulatory and hemodynamics per your facility's protocol and care guidelines, and complete and and return the enclosed Response Form by email to: MCPrecall2016@maquet.com or fax to: 1-973-629-1518 within three (3) business days. For any questions, please contact your Maquet sales and representative or Maquet Customer Service at 1-888-627-8383 (press option 2, followed by option 2) Monday through Friday, between the hours of 8:00am and 6:00pm EST.
Heater Cooler Unit Usage: The Heater-Cooler Unit (HCU 30) supplies temperature-controlled water for cardioplegia heat exchangers and for blood heat exchangers in extra corporeal circulation and for blankets with which patients can be warmed or cooled. The HCU 30 is intended to circulate water through heat exchange circuits to warm or cool a patient during short duration cardiopulmonary bypass procedures lasting 6 hours or less.
There is the potential for contaminated water to enter parts of the Heater-Cooler Unit circuits. There is a potential risk of bacterial contamination including Mycobacteria species.
Maquet issued an Urgent Medical Device Recall letter/Return Response form dated September 27, 2016 to affected customers. The letter identified the affected product, problem and actions to be taken. Customer were instructed to complete the return response form via fax to 1-973-629-1518. For questions contact Maquet Customer Service at 1-888-627-8383 option 2 followed by option 2 Monday through Friday between 8 amd and 6 pm. EST.
Quadrox-iD Adult Diffusion Membrane Oxygenator Product Usage: The Quadrox-iD Adult Diffusion Membrane Oxygenator is intended for use in an extracorporeal circulation during cardiopulmonary bypass in cardiac surgery. Within the specified flow rate range, the device oxygenates the blood, removes carbon dioxide from the blood and regulates the blood temperature. The oxygenator with diffusion membrane cannot be used for the administration of volatile anesthetic gases because the gas molecules are u
A potential issue was detected that could result in blood leakage from the gas outlet port in all lots of Quadrox-iD Adult Diffusion Membrane Oxygenator with Bioline and Softline Coatings, Custom Tubing Packs and Diffusion Membrane HLS Set Advanced and HIT Set Advanced Models.
Maquet sent a "Field Safety Notice" accompanied by a Response Form to their affected customers on 3/5/2015 via FedEx. The Field Safety Notice identified the affected products/Part numbers and actions to be taken by the user. The customers were asked to complete the Field Safety Notice Response Form to acknowledge that they have received the notice. The completed notice can be faxed to 1-973-396-3607 or sent via email to fieldactions@maquet.com. For any questions, customers can contact their Maquet Sales Representative or Maquet Customer Service at 1-888-627-8383 (press option 2, followed by option 2), Monday through Friday, between the hours of 8:00 a.m. and 6:00 p.m. EST.
QUADROX iD HMOD 2030 Diffusion Membrane Oxygenator; QUADROX-i ADULT HMO 70000 / HMO 71000; QUADROX-iD Pediatric HMOD 30000 Product Usage: The QUADROX oxygenators are intended for the use in extracorporeal circulation during cardiopulmonary bypass in cardiac surgery. Within the specified flow rate range, the device oxygenates the blood, eliminates carbon dioxide and regulates blood temperature. The devices utilization period is limited to six hours.
It has come to firm's attention that, in some rare cases, the blood outlet connector on some models of MAQUET Oxygenators may detach from the oxygenator. This event has occurred in about 0.01% (1:10,000) of units shipped.
Maquet sent a Field Safety Notices and Confirmation Forms dated June 13, 2012 to all affected customers. A Follow-up communication dated July 20, 2012 was mailed to all affected US customers. The Field Safety Notice identifies the problem, affected product, risk factors and actions to be taken by the customer. Customers were instructed to complete the Confirmation form and return in the self-addressed prepaid envelop. For questions call 201-995-8968. Maquet issued an updated Field Safety Notice/Field Safety Notice Confirmation Form dated 2/14/13 via Fed Ex on 2/18/2013. Maquet sent out an Updated Field Safety Notice/field Safety Notice Confirmation Form dated 4/4/2013 in order to notify customers they would be providing safety clamps.
QUADROX iD HMOD 2030 Diffusion Membrane Oxygenator; QUADROX-i ADULT HMO 70000 / HMO 71000; QUADROX-iD Pediatric HMOD 30000. The QUADROX oxygenators are intended for use in extracorporeal circulation during cardiopulmonary bypass in cardiac surgery.
The manufacturer has conducted a review of the results of product testing performed during the last twelve months and has identified specific lots of product which may not meet specifications for bond strength on the inlet and/or outlet connector.
Maquet sent a Urgent Product Recall letter/Response Form, dated 8/15/2013 via Fed Ex. On 8/26/2013 Maquet sent a letter to their customers informing them that all shipments of oxygenators and stainless steel hold clamps have been placed on a temporary hold due to an agency review in connection with FDA clearance. Customer service may be contacted at 1-888-627-8383, (option 2 followed by option 2) Monday though Friday between the hours of 8:00 am and 6:00 pm EST. Maquet issued a Certificate of Medical Neccesity (CMN) on September 17, 2013 to notify Quadrox customers that they may continue to receive and use their current inventory of Quadrox oxygenators and clamps by acknowledging the conditions provided in the CMN.