Recall Z-0052-2013 ยท KFM Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type
Terumo Cardiovascular Systems Corporation
Sarns Centrifugal System Control module, 220/240V The Sarns Centrifugal System is indicated for use in cardiopulmonary bypass procedures only.
| Date | Oct 11, 2012 (initiated Sep 24, 2012) |
| Status | Terminated |
| Reason | Terumo Cardiovascular Systems (Terumo CVS) received one report of loss of power to the control module and subsequently the drive motor for the Sarns centrifugal system during cardiopulmonary bypass. |
| Root cause | Component design/selection |
| Action | TERUMO sent an Urgent Medical Device Recall dated April 13, 2012, to all affected consignees. An Addendum was sent on September 25, 2012. All US Consignees will receive a Safety Advisory and an update to the Operator's Manual via Federal Express to inform them of the reported malfunction and potential hazards and to raise awareness of the benefits of using a retrograde valve and the importance of back-up system availability. TERUMO will include a customer response form and follow up with all affected users to obtain a response to the recall. For questions customers should call 1-800-521-2818 |
| Quantity | 213 units |
| Distribution | Worldwide Distribution - USA (nationwide) and the countries of Bangladesh, Seoul Korea, Chile, Brazil, Venesuela, Thailand, Mexico, India, Taiwan, Canada, Dominican Republic, Guatemala, Ecuador, Germany, Republic of Georgia, Hong Kong, Japan, United Arab Emirates (UAE), Japan, Belgium, Phillipines, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K882758 | CENTRIFUGAL PUMP SYSTEM LX/DX VERSION 3M Health Care, Sarns, Oct 13, 1988 |