BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PEDIATRIC 1/4 INCH ECC CUSTOM TUBING PACK

    MDR report key: 4253406 · Received November 12, 2014

    Report

    Report Number
    2248146-2014-00444
    Event Type
    Malfunction
    Date Received
    November 12, 2014
    Date of Event
    October 9, 2014
    Report Date
    October 15, 2014
    Manufacturer
    MAQUET CARDIOVASCULAR, LLC
    Product Code
    DTQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    AFTER INVESTIGATING THE RETURNED PRODUCT, THE ROOT CAUSE COULD NOT BE DETERMINED. AFTER VISUAL TESTING, AND FUNCTIONAL TESTING THE ROOT CAUSE OF THE CLOUDY HAZE COULD NOT BE DETERMINED. INTERNAL COMPLAINT NUMBER (B)(4).

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT YET BEEN RETURNED TO MAQUET CARDIAC SURGERY FOR EVALUATION. WE WILL FOLLOW UP WITH THE CUSTOMER FOR THE RETURN OF THE DEVICE. A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF THE DEVICE IS RECEIVED. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE 3/8 TUBING ON INFLOW AND OUTFLOW OF THE CONE IS COMPLETELY "GHOSTED" WITH FIBRIN WITHIN 24 HOURS OF INITIATING EXTRA CORPOREAL MEMBRANE OXYGENATION (ECMO). ALL THE OTHER TUBING (1/4 INCH) THROUGHOUT THE CIRCUIT REMAINED FINE. THIS WAS AN UNUSUAL OCCURRENCE, AND THE CUSTOMER IS CURIOUS AS TO WHY THIS SHOULD OCCUR ONLY ON THIS SECTION OF TUBING. NO UNUSUAL COAGULATION FOR THIS PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    729532 PEDIATRIC 1/4 INCH ECC CUSTOM TUBING PACK CARDIOPULMONARY DTQ MAQUET CARDIOVASCULAR, LLC 17465-01

    Patients

    Seq Age Sex Outcome Treatment
    1