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IMPELLA AIC PURGE RETAINER FRACTURE
In January 2024, Abiomed issued a safety alert regarding the purge retainer.
The company received field complaints, regarding fractured blue purge retainers in the AIC (Automatic Impella Console)
A thorough analysis of these failures revealed that consoles manufactured 4 or more years ago are more prone to purge assembly failure, and age likely contributes to material weakening of the purge disc retainer within the pressure sensor assembly
It may be also related with harsh cleaning agents and dextrose buildup from purge cassette leaks.
If the purge retainer is damaged, the AIC may not be able to recognize the connection of the purge disc, rendering the AIC unable to be used for Impella support
Abiomed recommendations are:
1. Carefully inspect the purge retainer assembly for any damage before support.
If damage is noticed, verify system functionality.
If functionality is compromised, report a complaint and return the console to the company.
Clean the assembly according to hospital protocol, as well as following any potential exposure to dextrose after a purge leak.
During cleaning, avoid products containing Isopropyl Alcohol or bleach.
To correctly change out a purge cassette, avoid removing a purge disc while the system is pressurized. Disconnect the yellow luer lock before removing the purge disc.
Source:
1. https://www.heartrecovery.com/resources/downloads/aic-purge-disc-retainer-and-purge-flag
