Catalog Number 0684-00-0475 |
Device Problem
Filling Problem (1233)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 05/10/2019 |
Event Type
malfunction
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Manufacturer Narrative
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Event site telephone: (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.Complaint record id # (b)(4).
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Event Description
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It was reported that during intra-aortic balloon (iab) therapy the console generated an autofill failure alarm.The balloon was replaced to continue therapy.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 with traces of blood on the exterior of the catheter.One kink was found on the catheter tubing near the y-fitting approximately 74.9cm from the iab tip.An underwater leak test of the balloon, catheter, y-fitting, extracorporeal tubing and extender tubing was performed and one (1) leak was detected on the membrane at approximately 17.5cm from the rear seal measuring 0.13cm in length.The reported alarm was most likely triggered by the leak was found on the membrane.The penetration found appears to have been caused by a sharp object.It is difficult to determine how or when the penetration may have occurred.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.Record id: (b)(4).
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Event Description
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It was reported that during intra-aortic balloon (iab) therapy the console generated an autofill failure alarm.The balloon was replaced to continue therapy.There was no reported injury to the patient.
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Search Alerts/Recalls
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