BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUADROX-ID, ADULT DIFF MEMB OXY- SOFTLINE COAT

    MDR report key: 4172354 · Received October 10, 2014

    Report

    Report Number
    8010762-2014-00802
    Event Type
    Injury
    Date Received
    October 10, 2014
    Date of Event
    September 15, 2014
    Report Date
    September 15, 2014
    Manufacturer
    MAQUET CARDIOPULMONARY AG
    Product Code
    DTZ
    PMA / PMN Number
    K101153
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    MAQUET CARDIOPULMONARY 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 OR BLOOD 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 CONFIRMS THAT 100 % FUNCTIONAL INSPECTION FOR LEAKAGE IS PERFORMED DURING PRODUCTION. MAQUET CARDIOPULMONARY (B)(4) HAS INITIATED AN INTERNAL PROCESS (CAPA-(B)(4)) TO ADDRESS THE APPROPRIATE CORRECTIVE AND PREVENTIVE ACTION. A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED WHEN ADDITIONAL INFO BECOMES AVAILABLE. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A CUSTOMER EXPERIENCED A LEAK IN THE BOTTOM OF THE DEVICE ONLY A FEW MINUTES AFTER INITIATING THERAPY. "PERHAPS A BROKEN FIBER OR NOT POTTED CORRECTLY". THE PT LOST APPROXIMATELY 5 ML OF BLOOD DURING THE TEN MINUTES PRIOR TO CHANGE OUT, IN ADDITION TO WHATEVER WAS IN THE DEVICE AT CHANGE OUT. THE PT WAS OFF OF ECMO FOR APPROXIMATELY 60 SECONDS DURING CHANGE OUT. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    642728 QUADROX-ID, ADULT DIFF MEMB OXY- SOFTLINE COAT OXYGENATOR, CARDIOPULMONARY BYPASS DTZ MAQUET CARDIOPULMONARY AG BEQ-HMOD70000 70097381

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention