Device product
TandemHeart pump is assembled into kits: TandemLife Kit Product: 5740-0000 - Product Usage: provides temporary extracorporeal circulatory system support with the unique ability to locally deliver an anticoagulant through the infusion system.
Z-1955-2020
Product summary
- Event
- Event 85322
- Status
- Terminated
- Classification
- Class II
- Quantity
- 13
- Official record key
device-enforcement:Z-1955-2020
Official wording
Reason: Failure to prime due to an assembly error
Code information: Serial Numbers: 00142463 00142464 00142465 00142469 00142470 00142471 00142472 00142478 00142479 00142480 00142481 00142482 00142483
Distribution pattern: US Nationwide distributions.
Derived failure modes
-
Manufacturing or process control
assembly error