Catalog Number 0684-00-0475 |
Device Problem
Display or Visual Feedback Problem (1184)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 11/28/2018 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(6).The product has been returned to the manufacturer, but is pending investigation.Once the investigation is completed a supplemental report with our findings will be submitted.(b)(4).
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Event Description
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It was reported that an hour after the intra-aortic balloon (iab) catheter was inserted, a "check iab catheter" alarm was generated and blood was found in the tubing.The iab was replaced with a new iab and therapy continued successfully.There was no reported injury to the patient.
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Event Description
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It was reported that an hour after the intra-aortic balloon (iab) catheter was inserted, a "check iab catheter" alarm was generated and blood was found in the tubing.The iab was replaced with a new iab and therapy continued successfully.There was no reported injury to the patient.
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Manufacturer Narrative
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The product was returned with the membrane completely unfolded and blood on the exterior of the catheter.The extender tubing was also returned.The catheter tubing was observed to be flattened along its length.This may occur if a vacuum is held with the one-way valve attached for a long period of time on the catheter causing the catheter tubing to lose its round shape.The inner lumen was found to be occluded with dried blood.The occlusion was able to be cleared.An underwater leak test of the balloon, catheter, y-fitting, extracorporeal and extender tubing was performed and three leaks were detected on the membrane at the same location on opposite sides approximately 21.6cm from the rear seal measuring 0.076cm in length.The reported problem was most likely triggered by leaks which was found on the membrane.The penetrations found on the membrane appear to have been caused by a sharp object.We are unable to determine when this may have occurred.A device and lot history record review was completed for the reported product.No nonconformances were found that are considered to be related to the event.Complaint # (b)(4), record # (b)(4).
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Search Alerts/Recalls
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