DATASCOPE CORP. - MAHWAH CARDIOSAVE HYBRID TYPE B PLUG; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
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Model Number N/A |
Device Problem
Gas Output Problem (1266)
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Patient Problem
Death (1802)
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Event Date 07/31/2020 |
Event Type
Death
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Manufacturer Narrative
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The production device history record (dhr) for this intra-aortic balloon pump (iabp) was reviewed and no non-conformances related to the reported event were noted.A getinge service territory manager (stm) evaluated the iabp and confirmed a sole incident of gas gain error in the diagnostic fault logs but could not replicate the error.The stm performed functional testing and safety checks to factory specifications which all passed, and the iabp unit was returned to the customer and cleared for patient use.
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Event Description
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It was reported that during use on a patient, the cardiosave intra-aortic balloon pump (iabp) had a gas gain error.The iabp was swapped for another and functioned properly with no alerts.No patient harm, serious injury or adverse event was reported.It was reported that the intra-aortic balloon catheter (iabc) was removed after a few hours for comfort care and the patient subsequently expired.Additionally, the customer advised that the patient expired because of sickness, and that they were not filing complaint on our hardware or balloon.A separate report will be submitted for the iabc involved.
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Manufacturer Narrative
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Updated fields: h6 (evaluation method code).
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Event Description
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It was reported that during use on a patient, the cardiosave intra-aortic balloon pump (iabp) had a gas gain error.The iabp was swapped for another and functioned properly with no alerts.No patient harm, serious injury or adverse event was reported.It was reported that the intra-aortic balloon catheter (iabc) was removed after a few hours for comfort care and the patient subsequently expired.Additionally, the customer advised that the patient expired because of sickness, and that they were not filing complaint on our hardware or balloon.A separate report will be submitted for the iabc involved.
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