Catalog Number 0684-00-0497 |
Device Problems
Air Leak (1008); Backflow (1064)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 10/24/2017 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(6).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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After two days of intra-aortic balloon therapy, it was reported that there was helium loss in the intra-aortic balloon catheter and blood was seen in the tubing.The intra-aortic balloon was replaced and therapy continued successfully.There was no reported injury to the patient.
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Manufacturer Narrative
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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.Complaint # (b)(4).
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Event Description
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After two days of intra-aortic balloon therapy, it was reported that there was helium loss in the intra-aortic balloon catheter and blood was seen in the tubing.The intra-aortic balloon was replaced and therapy continued successfully.There was no reported injury to the patient.Additional information: the customer did not believe there was iab pump problem however the pump showed "heliumleck" and the customer was unsure if there was an alarm associated with it.The customer could not fill the helium pump.
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Manufacturer Narrative
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Date received by mfr changed from: 10/24/2017 to: 11/24/2017.Device evaluation: the product was returned with the membrane completely unfolded and blood on the interior and exterior of the catheter.The extender tubing was also returned.An underwater leak test of the balloon, catheter, y-fitting, extracorporeal and extender tubing was performed and one leak was detected on the membrane approximately 1.3cm from the rear seal measuring 0.025cm in length.The reported alarms 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.The evaluation confirmed the reported problems.An abrasion leak is a known inherent risk and common failure mode 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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After two days of intra-aortic balloon therapy, it was reported that there was helium loss in the intra-aortic balloon catheter and blood was seen in the tubing.The intra-aortic balloon was replaced and therapy continued successfully.There was no reported injury to the patient.Additional information: the customer did not believe there was iab pump problem however the pump showed "heliumleck" and the customer was unsure if there was an alarm associated with it.The customer could not fill the helium pump.
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Search Alerts/Recalls
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