Recall Z-0050-2013 ยท KFM Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type
Terumo Cardiovascular Systems Corporation
Battery, 220V (Includes charger and connecting cable) The Sarns" Centrifugal System is indicated for use in cardiopulmonary bypass procedures only.
| Date | Oct 11, 2012 (initiated Sep 25, 2012) |
| Status | Terminated |
| Reason | Terumo Cardiovascular Systems (Terumo CVS) has received multiple reports since 2004 of various malfunctions of the battery backup system for the Sarns" Centrifugal System. The reports can be broadly categorized as follows: " Failure to charge " Failure to hold charge " Failure to operate In the most severe case, a battery malfunction could result in an unexpected loss of arterial flow. In |
| Root cause | Component design/selection |
| Action | TERUMO sent an Urgent Medical Device Recall letter dated June 25, 2012, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. On 09/25/2012 an URGENT MEDICAL DEVICE RECALL notification and addendum was sent to all consignees. TCS issued this notification as a Safety Advisory to alert all users of the Sarns centrifugal system of the potential for malfunction and remind them to review the appropriate sections of the Operators Manual for the Sarns Delphin Battery. Providing an addendum to the Operators Manual for the Sarns Delph |
| Quantity | 289 units |
| Distribution | Worldwide distribution: USA including: AK, AL, AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MI, MN, MO, MS, NC, NE, NH, NJ, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, UT, VA, WA, WI, and WV. Puerto Rico and internationally to: ALEXANDRIA, ARGENTINA, AUSTRALIA, AUSTRIA, B |
| 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 |