—#104991

Product

The Terumo Advanced Perfusion System 1, Catalog Number 801764 System 1 Base, 220 V Product Usage: The 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.

FDA product code: DTQ — Console, Heart-Lung Machine, Cardiopulmonary Bypass
Device class: Class 2
Medical specialty: Cardiovascular
510(k) numbers: K022947
Affected lot / code info: Lot numbers: 0006-1415; Catalog # 801764 System 1 Base, 220 V

Why it was recalled

1 US customer was operating the Advanced Perfusion System 1 with an unapproved, modified cable, which was in product development, to connect the system an an occluder for the Sarns Modular Perfusion System 8000 . Five(5)of twelve(12) cables from Terumo Japan, which were in product development, were given to a US customer.

Root cause (FDA determination)

Component design/selection

Action the firm took

Terumo sent an URGENT MEDICAL DEVICE CORRECTION: Recall Notification dated November 8, 2011 to all affected customers. The letter described the reason for the recall, known/potential hazards and request immediate location and correction of product. The letter instructs customers to stop using the modified cables and return to Terumo for replacement and destruction. Customers were asked to complete the attached response form and fax to the number indicated on the form. All affected customers will be receiving a safety advisory to advise them that Terumo do not recommend the alternative configuration of a System 1 Base with an 8K Occluder. For questions or concerns contact Terumo CVS Customer Service at 1-800-521-2818 or 1-800-292-6551 (fax).

Recalling firm

Firm: Terumo Cardiovascular Systems Corporation
Address: 6200 Jackson Road, Ann Arbor, Michigan 48103-9586

Distribution

Distribution pattern: Worldwide Distribution - (USA) Nationwide Distribution

Timeline

Recall initiated: 2011-11-08
Posted by FDA: 2011-11-29
Terminated: 2012-08-22
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #104991. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.