FDA Device

Roller Pump, 4 Inch Diameter The Terumo Advanced Perfusion System 1 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

Terumo Cardiovascular Systems (Terumo CVS) discovered and rejected a single digital encoder cable assembly during incoming inspection because it had a loose wire. The assembly is used in the 4" and the 6" roller pumps for the Terumo Advanced Perfusion System 1.

What You Should Do

Remedy

TERUMO sent an Urgent Medical Device Correction letter dated January 13, 2012, to all affected consignees. The letter identified the product, the problem, and the action to be taken by the consignee. Consignees were instructed to review the Medical Device Correction notice. Assure that all users are aware of the notice. Confirm receipt of the communication by faxing the attached Customer Response Form to 1-900-292-6551. Roller pumps with affected cables will have the cables assembly replaced. For questions regarding this recall call 1-800-521-2818.

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Products

Roller Pump, 4 Inch Diameter The Terumo Advanced Perfusion System 1 is indicated for use for up to 6 hours on the extracorporeal circulation of blood for arterial perfusion, regional perfusion, and c
Brand
Terumo Cardiovascular Systems Corporation
UPC
Catalog Number 816570; Serial Numbers: 5939 - 5962

Units Affected

44

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