Device product
Maquet Cardiopulmonary Bypass Custom Tubing kit BO-TOP 38600 ADULT CPB, Part Number 701056035 Product Usage: The Maquet Cardiopulmonary Bypass Custom Tubing kit is a sterile, non-pyrogenic device for single use only and is not to be re-sterilized by the user. The product consists of tubing and connectors with connected oxygenators, reservoirs, filters and other cardiopulmonary bypass components assembled into user specified circuits for procedures requiring extracorporeal support for up to six hours. See Attachment 6 for a copy of MCP Instructions for Use.
Z-2178-2018
Product summary
- Event
- Event 80081
- Status
- Terminated
- Classification
- Class II
- Quantity
- 10
- Official record key
device-enforcement:Z-2178-2018
Official wording
Reason: There is a potential for the over-pressure safety (OPS) valve in the tubing kits to not allow flow through.
Code information: UDI 0607567204133
Distribution pattern: The products were distributed to the following US states: IA and FL.
Derived failure modes
-
Unknown
There is a potential for the over-pressure safety (OPS) valve in the tubing kits to not allow flow through.