Catalog Number IAB-06840-U |
Device Problem
Insufficient Information (3190)
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Patient Problems
Cardiomyopathy (1764); No Consequences Or Impact To Patient (2199)
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Event Date 08/15/2016 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).Sample not returned to manufacturer.
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Event Description
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It has been reported that the event involved a patient, 163cm in height.While in the cath lab the intra-aortic balloon (iab) was prepped and inserted sheathless via the patient's right axillary site.The patient was moved to the cvicu.During intra-aortic balloon pump (iabp) therapy there was an issue and the iab was removed.Another iab was inserted into the same insertion site.There was a delay in iabp therapy, however no harm caused to the patient.There was no reported patient death, injury or complications.Medical / surgical intervention was required and described as: "removal and reinsertion of balloon." the pump used for the iabp therapy was a competitor's pump.
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Manufacturer Narrative
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(b)(4).On (b)(6) 2016 call received from risk manager.This catheter was not saved patient had (vre) vancomycin-resistant enterococci this is the second catheter for this patient, there was a leak cause unknown.No product was returned for evaluation.The specific serial number/lot number was not reported, but a device history record (dhr) review was conducted for all the lot numbers at this account with no relevant findings.All devices passed all manufacturing specifications prior to release.The reported complaint of leak (suspected) is not able to be confirmed.No product was returned for evaluation.The root cause of the complaint is undetermined.
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Event Description
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It has been reported that the event involved a patient, (b)(6) in height.While in the cath lab the intra-aortic balloon (iab) was prepped and inserted sheathless via the patient's right axillary site.The patient was moved to the cvicu.During intra-aortic balloon pump (iabp) therapy there was an issue and the iab was removed.Another iab was inserted into the same insertion site.There was a delay in iabp therapy, however no harm caused to the patient.There was no reported patient death, injury or complications.Medical / surgical intervention was required and described as: "removal and reinsertion of balloon." the pump used for the iabp therapy was a competitor's pump.
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Search Alerts/Recalls
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