Device product
TandemHeart pump is assembled into kits: ProtekDuo Kit - DL31 RD, Product: 5720-3631 - Product Usage: provides temporary extracorporeal circulatory system support with the unique ability to locally deliver an anticoagulant through the infusion system.
Z-1953-2020
Product summary
- Event
- Event 85322
- Status
- Terminated
- Classification
- Class II
- Quantity
- 6
- Official record key
device-enforcement:Z-1953-2020
Official wording
Reason: Failure to prime due to an assembly error
Code information: Serial Numbers: 00142676 00142677 00142678 00142679 00142680 00142910
Distribution pattern: US Nationwide distributions.
Derived failure modes
-
Manufacturing or process control
assembly error