Catalog Number 0684-00-0549-01 |
Device Problem
Backflow (1064)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 10/27/2017 |
Event Type
malfunction
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Manufacturer Narrative
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The device has not been returned to the manufacturer, so we are unable to complete an evaluation.If provided, we will send a supplemental report with our additional findings.(b)(4).
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Event Description
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It was reported that during intra-aortic balloon (iab) therapy blood back was noted in the iab.Removed iab and ended therapy.Patient's pressure was stable.No patient injury was reported.
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Manufacturer Narrative
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The product was returned with the membrane completely unfolded and blood on the interior and exterior of the catheter and between the catheter and the sheath.The extracorporeal tubing was returned with the male luer cut.The returned sheath was over the catheter but it was not a maquet product.An underwater leak test of the balloon, catheter, y-fitting and extracorporeal tubing was performed and one leak was detected on the membrane approximately 1.8cm from the rear seal measuring 0.03cm in length.The evaluation confirms the reported leak, blood in tubing problem.The reported blood in tubing was most likely triggered by a leak which was found on the membrane.Under magnification, a whitish patch was observed around the leak.This whitish patch is the typical appearance of an abrasion mark which is caused by calcified plaque in the aorta.A device and lot history record review was completed for the reported product.No non-conformances were found that are considered to be related to the event.Complaint # (b)(4).
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Event Description
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It was reported that during intra-aortic balloon (iab) therapy blood back was noted in the iab.Removed iab and ended therapy.Patient's pressure was stable.No patient injury was reported.
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Search Alerts/Recalls
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