System 8000 Base Product Usage: The Sarns Modular Perfusion System 8000 is indicated for use for up to 6 hours on the extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures, when used by a qualified medical professional who is experienced in the operation of this or similar equipment.
Hazard
During a retrospective review of complaint events, TCVS identified on 06/15/12 that three (3) Sarns" System 8000 bases were manufactured and distributed from 11/13/06-11/29/06 with an incorrect incorrect amperage rating identified on the name plate label. The mislabeling was identified in January 2007 a set up process of the automark label printer. All units were corrected in the field in Marc
What You Should Do
Remedy
Terumo field correction/service records were completed in 2007 and all affected units were corrected in the field in March 2007 by replacing the incorrect label at the customer location. For questions about this report call 734-741-6056.
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Products
System 8000 Base
Product Usage:
The Sarns Modular Perfusion System 8000 is indicated for use for up to 6 hours on the extracorporeal circulation of blood for arterial perfusion, regional perfusion, a
- Brand
- Terumo Cardiovascular Systems Corporation
- UPC
- catalog number: 16401 and serial number: 2001, 2002, and 2003.
Units Affected
3