Device product
Alaris Pump Module, Model 8100, serviced/repaired by Step-Har Medical with an impacted bezel repair part
Z-1543-2021
Product summary
- Event
- Event 87773
- Status
- Terminated
- Classification
- Class I
- Quantity
- 2
- Official record key
device-enforcement:Z-1543-2021
Official wording
Reason: Bezel repair parts used, not by the original manufacturer, to service and repair infusion pump modules, may over time experience cracking or separation of the posts from the bezel. The separation of one or more bezel repair part posts may result in free flow, over infusion, under infusion or interruption of infusion.
Code information: Serial Numbers: 12747983 and 9919591
Distribution pattern: IA
Derived failure modes
-
Unknown
Bezel repair parts used, not by the original manufacturer, to service and repair infusion pump modules, may over time experience cracking or separation of the posts from the bezel. The separation of one or more bezel repair part posts may result in free flow, over infusion, under infusion or interruption of infusion.