BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BEQ-HMOD70000-USA QUADROX-ID OXYGENATOR

    MDR report key: 3983591 · Received July 1, 2014

    Report

    Report Number
    8010762-2014-00250
    Event Type
    Injury
    Date Received
    July 1, 2014
    Date of Event
    June 7, 2014
    Report Date
    June 30, 2014
    Manufacturer
    MAQUET CARDIOPULMONARY AG
    Product Code
    DTZ
    PMA / PMN Number
    K101153
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE HAS NOT BEEN RECEIVED FOR EVALUATION. MAQUET CARDIOPULMONARY (B)(4) IS AWARE OF SIMILAR COMPLAINTS. THE DEVICES DISPLAYED A SIMILAR MALFUNCTION WHICH WERE TESTED AND EVALUATED UNDER AN OPTICAL MICROSCOPE. DELAMINATION OF SOME GAS FIBERS WAS OBSERVED WHICH ALLOWED FOR THE PRIMING SOLUTION TO FLOW INSIDE THE GAP BETWEEN THE GAS FIBERS AND POLYURETHANE. GRAVITY THEN ALLOWED FOR PASSAGE TO THE GAS EXITING PATH ALONG THE HOUSING. THE MOST PROBABLE ROOT-CAUSE IS THE DELAMINATION OF THE HOLLOW GAS FIBERS FROM THE POLYURETHANE POTTING AREA. A REVIEW OF THE QUALITY CONTROL PROCESS INDICATES THAT A 100 PERCENT FUNCTIONAL INSPECTION FOR LEAKAGE IS PERFORMED IN THE MANUFACTURING AREA. A REVIEW OF THE PRODUCTION RECORDS FOR THIS PARTICULAR LOT SHOW THAT THE DEVICE PASSED THE 100 PERCENT TIGHTNESS TEST. MAQUET CARDIOPULMONARY (B)(4) HAS INITIATED AN INTERNAL PROCESS (CAPA(B)(4)) TO ADDRESS THE APPROPRIATE CORRECTIVE AND PREVENTIVE ACTION. (B)(4). THIS EVENT IS RELATED TO MEDWATCH REPORT# 8010762-2014-00251 AND (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER ECMO WAS INITIATED, A SLOW DRIP ORIGINATED FROM THE EMERGENCY EXHAUST POST ON THE BOTTOM OF THE DEVICE. THE DEVICE WAS REPLACED WITH ANOTHER OF THE SAME LOT NUMBER. AFTER ONE HOUR, THE REPLACEMENT DEVICE BEGAN TO LEAK, SO IT WAS REPLACED WITH A DEVICE OF DIFFERENT LOT. NO REPORTED PT EFFECT. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    384672 BEQ-HMOD70000-USA QUADROX-ID OXYGENATOR DIFFUSION MEMBRANE OXYGENATOR DTZ MAQUET CARDIOPULMONARY AG 70095119

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention