Device product
TandemHeart Pump Kit, Product: 5120-0000 - Product Usage: provides temporary extracorporeal circulatory system support with the unique ability to locally deliver an anticoagulant through the infusion system.
Z-1948-2020
Product summary
- Event
- Event 85322
- Status
- Terminated
- Classification
- Class II
- Quantity
- 10
- Official record key
device-enforcement:Z-1948-2020
Official wording
Reason: Failure to prime due to an assembly error
Code information: Serial Numbers: 00142577 00142578 00142579 00142656 00142675 00142944 00142946 00142947 00142960 00142961
Distribution pattern: US Nationwide distributions.
Derived failure modes
-
Manufacturing or process control
assembly error