Catalog Number 0998-00-0800-XX |
Device Problem
Pumping Stopped (1503)
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Patient Problems
Cardiopulmonary Arrest (1765); Death (1802); Ventricular Fibrillation (2130)
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Event Date 02/10/2018 |
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.Additional information has been requested, and we will report accordingly if it becomes available.
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Event Description
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It was reported that while delivering intra-aortic balloon pump therapy with a cs300 to a patient, the patient coded and went into ventricular fibrillation.During this event, the iabp lost ecg trigger and stopped pumping.The patient expired during this event and the customer is requesting that the iabp be thoroughly checked out before being put back into service.No specific issue with iabp was cited.The patient's death is not being attributed to the iabp.
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Manufacturer Narrative
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Corrected: (catalog number to 0998-00-0800-xx and (b)(4)).A getinge (b)(4) (stm) evaluated the iabp and found no problem during his inspection.The iabp passed all functional and safety tests to factory specifications, returned to customer and cleared for clinical use.
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Event Description
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It was reported that while delivering intra-aortic balloon pump therapy with a cardiosave to a patient, the patient coded and went into ventricular fibrillation.During this event, the iabp lost ecg trigger and stopped pumping.The patient expired during this event and the customer is requesting that the iabp be thoroughly checked out before being put back into service.No specific issue with iabp was cited.The patient's death is not being attributed to the iabp.
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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.
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Event Description
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It was reported that while delivering intra-aortic balloon pump therapy with a cardiosave to a patient, the patient coded and went into ventricular fibrillation.During this event, the iabp lost ecg trigger and stopped pumping.The patient expired during this event and the customer is requesting that the iabp be thoroughly checked out before being put back into service.No specific issue with iabp was cited.The patient's death is not being attributed to the iabp.
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Search Alerts/Recalls
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