Catalog Number 0684-00-0575 |
Device Problems
Display or Visual Feedback Problem (1184); Filling Problem (1233); Defective Component (2292); Noise, Audible (3273)
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Patient Problems
No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
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Event Date 04/03/2019 |
Event Type
malfunction
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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.(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 which prevented further pumping.A hissing sound was reported at the hub where the arterial lumen and helium tubing join the catheter.The patient was taken to surgery.The insertion was reported to be axillary, which is not the method described in the device instructions for use.There was no reported injury to the patient.
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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 which prevented further pumping.A hissing sound was reported at the hub where the arterial lumen and helium tubing join the catheter.The patient was taken to surgery.The insertion was reported to be axillary, which is not the method described in the device instructions for use.There was no reported injury to the patient.
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Manufacturer Narrative
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Brand name: sensation plus 8fr.50cc iab.Serial number: (b)(4).Lot number: 3000086897.Expiration date: 12/18/2021.Manufacturing date: 12/18/2018.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 returned sheath was a non-maquet device and was returned over the catheter by a membrane taper only.The pressure tubing was also returned.The catheter was found to be separated into two separate pieces within a kink near the y-fitting approximately 73.4cm from the iab membrane tip.The optical fiber was found to be broken at this location.The iab tip was not attached to the membrane and was not returned.An underwater leak test of the balloon, catheter, y-fitting, extracorporeal and pressure tubing was performed and confirmed a leak at the two broken locations.The break found near the y-fitting appears to have been the result of a severe kink, which eventually failed and allowed blood to leak into the membrane and catheter tubing causing the reported alarm and damaged component problems.It is difficult to determine when the break occurred but it is possibly a result of patient movement during the procedure.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.Reference complaint #: (b)(4); record id: (b)(4).
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Search Alerts/Recalls
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