BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BE-01970311-PLS#D-QUADROX-I ADU.O.FILTER

    MDR report key: 4162721 · Received October 8, 2014

    Report

    Report Number
    8010762-2014-00789
    Event Type
    Injury
    Date Received
    October 8, 2014
    Date of Event
    September 6, 2014
    Report Date
    September 9, 2014
    Manufacturer
    MAQUET CARDIOPULMONARY AG
    Product Code
    DTZ
    PMA / PMN Number
    K082117
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION IS STILL PENDING. A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED WHEN ADDITIONAL INFO BECOMES AVAILABLE. THIS REPORT IS RELATED TO MEDWATCH REPORT # 8010762-2014-00781 AND 8010762-2014-00782 AND 7010762-2014-00788.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE INITIATING ECMO (EXTRA CORPOREAL MEMBRANE OXYGENATION) WITH A SECOND DEVICE, THE FLOW WOULD NOT EXCEED 500 ML/MIN. THE ECMO LINES WERE NOTED TO BE CLOTTED DESPITE CONTROLLED ANTICOAGULATION. THE DEVICE WAS REPLACED. DURING THIS EVENT, THE PT SUFFERED A HEART ATTACK AND HAD TO BE RESUSCITATED. TWO DAYS LATER THE PT RESIDES IN INTENSIVE CARE. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    633714 BE-01970311-PLS#D-QUADROX-I ADU.O.FILTER QUADROX-I ADULT OXYGENATOR DTZ MAQUET CARDIOPULMONARY AG BE-01970311-PLS 70098205

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R