BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUADROX-I ADULT OHNE FILTER

    MDR report key: 4203596 · Received October 23, 2014

    Report

    Report Number
    8010762-2014-01067
    Event Type
    Injury
    Date Received
    October 23, 2014
    Date of Event
    August 20, 2014
    Report Date
    September 23, 2014
    Manufacturer
    MAQUET CARDIOPULMONARY AG
    Product Code
    DTZ
    PMA / PMN Number
    K082117
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION IS STILL PENDING. A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED WHEN ADDITIONAL INFO BECOMES AVAILABLE. THIS EVENT IS RELATED TO MEDWATCH REPORT # 8010762-2014-01086 AND 8010762-2014-01087. ADDITIONAL INFORMATION PROVIDED - A HLS ADULT TUBING SET WAS USED FOR A CHILD, WHICH IS NOT FORESEEN FOR USE IN CHILDREN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A ECLS (EXTRACORPOREAL LIFE SUPPORT) RUN, BLOOD FLOW WAS STEADY AT 2.2 LITERS/MINUTE. HEMOLYSIS WAS OBSERVED DURING THE ENTIRE TREATMENT. THE FIRST OXYGENATOR DISPLAYED HEMOLYSIS AND WAS CHANGED OUT. THE SECOND DEVICE WAS EXCHANGED DUE TO CLOTTING. THE THIRD DEVICE DISPLAYED HEMOLYSIS AND WAS ALSO EXCHANGED. IT WAS ALSO REPORTED THAT WHEN HEPARIN WAS SIGNIFICANTLY LOW DUE TO BLOOD COMPLICATIONS, THERE WERE ISSUES WITH OXYGENATION AND VENTILATION. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    675874 QUADROX-I ADULT OHNE FILTER OXYGENATOR, CARDIOPULMONARY BYPASS DTZ MAQUET CARDIOPULMONARY AG BE-015703112 70098765

    Patients

    Seq Age Sex Outcome Treatment
    1 11 YR Required Intervention