—#64429

Product

Terumo Advanced Perfusion System 1 (6 inch diameter Roller Pump; Model 801041). 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: Serial numbers 0030, 0032 through 0587, 0700 through 1936, 1947 through 1951 and 2000 through 2799.

Why it was recalled

Overspeed and underspeed errors, erratic pump behavior, jerky operation at low RPMs, pump instability, pump slowdowns and pump stops due to overspeed max events may occur due to a grease leak onto the motor speed encoder disk.

Root cause (FDA determination)

Component design/selection

Action the firm took

Consignees were notified of the problem via recall letter dated 7/18/08. The firm began conducting field upgrades on the roller pumps in 07/08. For questions or concerns, contact Terumo CVS Customer Service at 1-800-521-2818.

Recalling firm

Firm: Terumo Cardiovascular Systems Corporation
Address: 6200 Jackson Rd, Ann Arbor, Michigan 48103

Distribution

Distribution pattern: Worldwide Distribution including USA and countries of Australia, Belgium. Canada, Columbia, 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: 2008-07-18
Posted by FDA: 2008-12-11
Terminated: 2009-07-07
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #64429. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.