—#75750

Product

Terumo Advanced Perfusion System 1; 220V -240V, 7A (circuit breaker), 50/60 Hz (10A power source required) base, Terumo Cardiovascular Systems, Ann Arbor, MI. Model 801764. (Not distributed within the United States). The device is indicated for use in the extracorporeal circulation of blood for arterial perfusion and cardiopulmonary bypass procedures by a perfusionist.

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: Serial Numbers: 0006 through 0066, 0100 through 0322, 1001 through 1027 and 1100 through 1161.

Why it was recalled

The power manager board may cause a short circuit, resulting in loss of system power, loss of central control monitor or electrical arcing.

Root cause (FDA determination)

Nonconforming Material/Component

Action the firm took

An "Urgent Medical Device Correction" letter was sent to consignees on November 7, 2008. The letter described the reason for correction and provided instructions to customers. Terumo Cardiovascular Systems Corporation will replace the power manager boards on the affected devices. Customers were instructed to complete and fax the Customer Response Form to CVS Customer Service at 1-800-292-6551 (US only) or respond by telephone at 1-800-521-2818. Please direct questions to CVS Customers Service at 1-800-521-2818.

Recalling firm

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

Distribution

Distribution pattern: Worldwide Distribution including USA and countries of Australia, Belgium, Canada, Columbia, Costa Rica, Dominican Republic, Egypt, Germany, Honduras, Hong Kong, India, Indonesia, Israel, Japan, Jordan, Kuwait, Malaysia, Mexico, Pakistan, Philippines, Russia, Saudi Arabia, Singapore, South Africa, South Korea, Taiwan, Thailand, Turkey, United Arab Emirates and Viet Nam.

Timeline

Recall initiated: 2008-11-07
Posted by FDA: 2009-02-24
Terminated: 2009-07-07
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #75750. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.