Catalog Number 0684-00-0549-03 |
Device Problem
Device Operates Differently Than Expected (2913)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 11/21/2017 |
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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On (b)(6) 2017, the intra-aortic balloon (iab) catheter was inserted in the patient in the femoral artery.On (b)(6) 2017, there was a ¿blood detected¿ alarm generated during use on a patient.The procedure was completed with replacement of the iab catheter.There was evidence of aortic calcification.No patient injury was reported.
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Manufacturer Narrative
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The iab was returned with the membrane completely unfolded.No blood was visible on the catheter.The extension tube was also returned.An underwater leak test of the balloon, catheter, y-fitting and extracorporeal and extension tubing was performed and no leaks were detected.The iab was placed on the cs300 pump and pumped for two hours which represents one complete auto fill cycle.The iab pumped normally and no alarm sounded from the pump.The reported event cannot be confirmed by the evaluation.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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On (b)(6) 2017, the intra-aortic balloon (iab) catheter was inserted in the patient in the femoral artery.On (b)(6) 2017, there was a ¿blood detected¿ alarm generated during use on a patient.The procedure was completed with replacement of the iab catheter.There was evidence of aortic calcification.No patient injury was reported.
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Search Alerts/Recalls
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