Catalog Number 0998-00-0800-53 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Death (1802); Loss of consciousness (2418)
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Event Date 02/12/2017 |
Event Type
Injury
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Manufacturer Narrative
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The device history record (dhr) for the iabp involved in the event was reviewed.There were no non-conformances noted in the dhr related to the reported event.
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Event Description
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It was reported by the customer: patient unresponsive, we did a cardiac intervention "after" case placed the iabp through an 8fr sheath very easily, plugged in and no ao waveform was present.Tried plugging fiber optic into a different iabp machine and no ao waveform was present.Further, it was reported the customer is not attributing the adverse event (i.E.Patient death) to the device.This is 2 of 2 reports for the same event.
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Manufacturer Narrative
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The company account manager for this facility reported that there was no malfunction of the pump at the time of the event, and it performed perfectly.Further, the said representative reported that the only issue was with the iab catheter, and that issue was with specifically the fiber optic sensor on the iab catheter.A separate report was submitted under medwatch #2248146-2017-00025 addressing this alleged iab malfunction.
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Event Description
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It was reported by the customer: patient unresponsive, we did a cardiac intervention "after" case placed the iabp through an 8fr sheath very easily, plugged in and no ao waveform was present.Tried plugging fiber optic into a different iabp machine and no ao waveform was present.Further, it was reported the customer is not attributing the adverse event (i.E.Patient death) to the device.This is 2 of 2 reports for the same event.
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Search Alerts/Recalls
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