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SECURITY ALERT: CARDIOHELP EMERGENCY PRIMING LINE.
In December 2023, Getinge issued a safety alert regarding an potential insufficient packaging sterility of the emergency priming line.
Getinge informed of an issue related to HLS Sets that may affect the sterile barrier of the Emergency priming line.
The Emergency priming line is employed to remove air from from the membrane, only used in emergency situations.
During internal testing, it were discovered narrow channels in the sealing of the sterile bag of Emerg. Prim. Line, this could lead to a breach in the sterile barrier.
The aforementioned bag, is packed in the sterile tray with the rest of the HLS Set.
The company says that even with the potentially compromised sterile bag, the emergency priming line is sterile when opening an HLS Set for the first time.
If Emergency priming line is needed later, a new HLS Set should be opened to obtain a sterile emergency priming line.
The use of a non sterile line could expose patients to pathogens and lead to the following potential damages:
•Inflammation
•Infection
•Sepsis
The company has already taken action, informing its customers about the affected batches and the measures to be taken.
The recommendations are:
· Discard the Emergency priming line (EPL) from the affected HLS Set
· If necessary, use the (EPL) from a spare HLS Set
· Discard the remaining components of spare HLS Set
· Contact the company to replacement HLS Set or reimbursement.
