Device product
TandemHeart pump is assembled into kits: TandemHeart Kit - TS62/A17, Product: 5710-6217 - Product Usage: provides temporary extracorporeal circulatory system support with the unique ability to locally deliver an anticoagulant through the infusion system.
Z-1950-2020
Product summary
- Event
- Event 85322
- Status
- Terminated
- Classification
- Class II
- Quantity
- 15
- Official record key
device-enforcement:Z-1950-2020
Official wording
Reason: Failure to prime due to an assembly error
Code information: Serial Numbers: S/N 00142612 00142614 00142657 00142658 00142659 00142660 00142661 00142663 00142937 00142938 00142941 00142942 00142970 00142971 00142972
Distribution pattern: US Nationwide distributions.
Derived failure modes
-
Manufacturing or process control
assembly error