DATASCOPE CORP. - FAIRFIELD UNKNOWN INTRA-AORTIC BALLOON (IAB); SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
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Lot Number UNKNOWN |
Device Problem
Inflation Problem (1310)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Type
malfunction
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Manufacturer Narrative
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Occupation: peacehealth administrator 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.Reference complaint #(b)(4).
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Event Description
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It was reported that during intra-aortic balloon (iab) therapy, the balloon would not open.There was no patient harm or adverse event reported.
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Manufacturer Narrative
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Updated field(s): health professional? occupation: ms, arnp, cnor, fnp-bc, rn surgical specialist additional information received 09may2024.Updated field(s) - brand name serial # / lot # udi number catalog # manufacture date/ exp.Date.
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Event Description
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N/a.
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Event Description
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N/a.
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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.An underwater leak test of the balloon, catheter, y-fitting and extracorporeal tubing was performed and no leaks were detected.The iab was placed on the cardiosave pump and the iab fully inflated.No alarm sounded from the pump.The reported event cannot be confirmed by the evaluation.A 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).
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Search Alerts/Recalls
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