Terumo Perfusion System 8000 Roller Pump, 220/240V; Model 8000; Catalog No. 16407.
- Recall Initiated
- July 1, 2004
- Posted
- July 7, 2007
- Terminated
- December 12, 2007
- Recall Number
- Z-1003-2007
- Quantity
- 728 pumps of all models
- Firm Location
- Ann Arbor, MI
Reason for Recall
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.
Distribution
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.
Lot / Code Info
Serial numbers 10031, 10033, 10137, 10138, 10614, 10663, 10730, 11131, 11281, 11283, 11361, 11548, 11630, 11751, 12110, 12604, 12686, 12938, 13129, 13719, 13826, 13830, 14712, 15090, 15277, 15278, 15279, 15280, 15284, 15285, 15304, 16003, 16087, 16190, 17099, 17345, 17432 and 17437 through 18122 may be affected by the problem. Serial numbers 17442, 17718, 17854, 17933, 17860, 17948, 17953, 17954, 18078, 18079 and 18107 have been corrected.
Root Cause
Other
Action Taken
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