BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUADROX-I, QUADROX-ID, QUADROX-IR OXYGENATORS

    MDR report key: 4172375 · Received October 10, 2014

    Report

    Report Number
    8010762-2014-00799
    Event Type
    Injury
    Date Received
    October 10, 2014
    Date of Event
    September 14, 2014
    Report Date
    September 15, 2014
    Manufacturer
    MAQUET CARDIOPULMONARY AG
    Product Code
    DTZ
    PMA / PMN Number
    K132829
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    MAQUET CARDIOPULMONARY AG WILL NOT BE ABLE TO OBTAIN DEVICE FOR INVESTIGATION BECAUSE THE HOSPITAL DISCARDED IT. BASED ON THE FAILURE DESCRIPTION RECEIVED FROM THE HOSPITAL, THE MOST PROBABLE ROOT CAUSE COULD BE A DELAMINATION OF SOME GAS FIBERS FROM THE POLYURETHANE POTTING AREA. MAQUET CARDIOPULMONARY AG HAS INITIATED A CAPA PROCESS (CAPA-(B)(4)) TO INITIATE THE APPROPRIATE CORRECTIVE AND PREVENTIVE ACTION. THE PROCESS IS IN THE ROOT CAUSE ANALYSIS PHASE. MAQUET CARDIOPULMONARY AG WILL NOT BE ABLE TO CONFIRM THE FAILURE OF THE ACTUAL DEVICE. THE MOST PROBABLE ROOT-CAUSE WILL BE ADDRESSED THROUGH CAPA (B)(4), AS WELL AS CONTINUOUS MONITORING OF COMPLAINTS FOR TRENDS. A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED IF ADDITIONAL INFO BECOMES AVAILABLE. CAPA: (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT EXTRA CORPOREAL CIRCULATION WAS INITIATED AND WITHIN SEVERAL MINUTES BLOOD WAS LEAKING FROM THE BOTTOM OF THE DEVICE. THE DEVICE WAS CHANGED OUT AND THE LEAKING DEVICE WAS DISCARDED." (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    642582 QUADROX-I, QUADROX-ID, QUADROX-IR OXYGENATORS OXYGENATOR, CARDIOPULMONARY BYPASS DTZ MAQUET CARDIOPULMONARY AG 70097204

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention