—#50432

Product

Terumo Perfusion System 9000 Roller Pump; Model 9000; Catalog No. 16395.

FDA product code: DTQ — Console, Heart-Lung Machine, Cardiopulmonary Bypass
Device class: Class 2
Medical specialty: Cardiovascular
510(k) numbers: K915183, K953904
Affected lot / code info: Serial numbers 10374, 10770, 11059, 13422, 15071, 17466 through 18062 may be affected by the problem. Serial numbers 17706, 17718, 17854, 17933, 17860, 17948, 17953 and 17954 have been corrected.

Why it was recalled

Roller Pump: Due to a circuit board malfunction the roller pumps may stop during use without displaying an error message, may stop during use with an overspeed error posted on the local display, or may fail to start/restart resulting in the pump(s) being non-functional.

Root cause (FDA determination)

Other

Action the firm took

As the complaints were received (between 07/04 and 01/06), the firm visited the customer filing the complaint and repaired the pumps demonstrating the problem. The firm will correct other units as complaints are received. The firm modified its recall strategy and issued a Device Correction Letter dated 6/22/07 notifying all users of the problem

Recalling firm

Firm: Terumo Cardiovascular Systems Corp
Address: 6200 Jackson Rd, Ann Arbor, Michigan 48103-9586

Distribution

Distribution pattern: Worldwide: USA and Bangladesh, Belgium, Bolivia, Canada, Chile, Colombia, Costa Rica, Egypt, Equador, Hong Kong, India, Indonesia, Japan, Latin America, Malaysia, Nicaragua, Philippines, Saudi Arabia, Taipe, Taiwan, United Arab Emirates, Uruguay, and Viet Nam.

Timeline

Recall initiated: 2004-07-01
Posted by FDA: 2007-07-07
Terminated: 2007-12-12
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #50432. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.