Recall Z-1235-2017 ยท KFM Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type
Terumo Cardiovascular Systems Corporation
The Sarns Centrifugal Pump is a single use device sterilized by ethylene oxide gas. The device is sold single sterile in cartons of 8 units, or may be provided in bulk, non-sterile to another Terumo location for inclusion in Cardiovascular Procedure Kits. Cardiovascular Procedure kits are packaged individually.
| Date | Feb 22, 2017 (initiated May 27, 2015) |
| Status | Terminated |
| Reason | Terumo Cardiovascular Systems Corporation has received complaints indicating that the Sarns Centrifugal Pump (disposable pump heads) have exhibited leaks. The leaks were detected during priming of the bypass circuit and during CPB procedures. In each of the reported incidents, there were no reports of patient injury as a result of the centrifugal pump leaks. Terumo Cardiovascular System's investigation into the incident has identified the cause of the leaks to be cracks in both the Top Housing and Magnet Back Housing of the pump. When the cracks cause the housing to become compromised, it is |
| Root cause | Process control |
| Action | Customer Notification Letter/Response Form is being sent to all affected consignees. |
| Quantity | 579 units have entered into the distribution chain |
| Distribution | Terumo CVS has identified 33 domestic consignees and 0 international consignee that are affected by this recall |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K112229 | SARN CENTRIFUGAL PUMP Terumo Cardiovascular Systems, Dec 9, 2011 |