Maquet/Getinge—Datascope CARDIOSAVE Intra-Aortic Balloon Pumps​: Fluid Ingress May Affect Electronic Circuit Boards​

May 16, 2018 | Risk Management News


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In a May 4, 2018, Urgent Medical Device Correction letter submitted by ECRI Institute member hospitals, Maquet/Getinge states that fluid ingress may occur in the above intra-aortic balloon pumps (IABPs), potentially preventing initiation or continuation of therapy. Maquet/Getinge also states that liquid spills, such as saline, can create bridges of resistance between the circuit components that can prevent the circuit from functioning as intended. Maquet/Getinge further states that is has received one...

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