Catalog Number 0684-00-0434 |
Device Problem
Device Displays Incorrect Message (2591)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 12/08/2017 |
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 there was a fiber optic sensor failure alarm generated.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 and between the catheter and the sheath.The returned sheath was over the catheter but it was not a maquet product.The extension tubing was also returned.Four kinks were observed on the catheter tubing approximately 52.1cm, 52.6cm, 52.8cm and 76.2cm from the iab tip.The optical fiber was also found to be broken at this location.The optical fiber was found to be broken, confirming the reported problems.The evaluation confirmed the reported problem.It is difficult to determine when or how a break in the fiber optic occurs.However, a kink in the catheter can cause the fiber optic to break resulting in no signal or the inability to calibrate it.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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It was reported that during intra-aortic balloon (iab) therapy there was a fiber optic sensor failure alarm generated.There was no reported injury to the patient.
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Search Alerts/Recalls
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