Catalog Number 0684-00-0549-02 |
Device Problem
Unable to Obtain Readings (1516)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 12/06/2017 |
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, the iab optical sensor was unable to take (a reading) upon iab insertion and during therapy.Replaced iab to continue therapy.No patient injury was reported.
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Manufacturer Narrative
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While it was reported that the iab optical sensor was unable to take a reading, it should be noted that this iab version does not use an optical sensor to obtain a pressure reading, so the device has been evaluated for inability to obtain a reading via standard transducer method, through the inner lumen.The product was returned with the membrane completely unfolded and blood on the exterior of the catheter.Dried blood was found occluding the inner lumen.The occlusion was able to be cleared.The technician attempted to insert a 0.025¿ laboratory guide wire through the inner lumen of the returned iab and found that the inner lumen was occluded.The technician was able to clear the occlusion and dried blood was observed at the tip of the guide wire.The technician was able to successfully aspirate/flush the inner lumen.An underwater leak test of the balloon, catheter, y-fitting and extracorporeal tubing was performed and no leaks were detected.The evaluation confirmed the reported difficult/unable to monitor pressure problem.The condition of the iab as received indicated an occlusion.This can cause difficulty during pressure monitoring.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.(b)(4).
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Event Description
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It was reported that during intra-aortic balloon (iab) therapy, the iab optical sensor was unable to take (a reading) upon iab insertion and during therapy.Replaced iab to continue therapy.No patient injury was reported.
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Manufacturer Narrative
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Lot # changed from: 3000038795 to: 3000031561.Distributor name: (b)(4).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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It was reported that during intra-aortic balloon (iab) therapy, the iab optical sensor was unable to take (a reading) upon iab insertion and during therapy.Replaced iab to continue therapy.No patient injury was reported.
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Search Alerts/Recalls
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