Device product
Sorin Centrifugal Pump System, CP5, Drive Unit (Catalogue Item #60-01-04, UDI: 04033817900948) used in an HLM S5/C5 System configuration. A cardiopulmonary bypass speed control device.
Z-0787-2022
Product summary
- Event
- Event 89312
- Status
- Terminated
- Classification
- Class III
- Quantity
- 4
- Official record key
device-enforcement:Z-0787-2022
Official wording
Reason: One ferrite ring expected to be installed on centrifugal pump system power cable may not be present.
Code information: CP5 Drive Unit Serial Numbers: 60E03336 60E03339 60E03344 60E03347
Distribution pattern: US distribution in states of FL, TX, and NE
Derived failure modes
-
Unknown
One ferrite ring expected to be installed on centrifugal pump system power cable may not be present.