Device product
TandemHeart pump is assembled into kits: TandemHeart Kit - TS62/A15, Product: 5710-6215 - Product Usage: provides temporary extracorporeal circulatory system support with the unique ability to locally deliver an anticoagulant through the infusion system.
Z-1949-2020
Product summary
- Event
- Event 85322
- Status
- Terminated
- Classification
- Class II
- Quantity
- 5
- Official record key
device-enforcement:Z-1949-2020
Official wording
Reason: Failure to prime due to an assembly error
Code information: Serial Numbers: 00142681 00142683 00142949 00142950 00142951
Distribution pattern: US Nationwide distributions.
Derived failure modes
-
Manufacturing or process control
assembly error