BEUDAMED
    FDA Adverse Event Death Summary report: N

    CUSTOM TUBING PACK

    MDR report key: 111304 · Received August 7, 1997

    Report

    Report Number
    2022036-1997-00047
    Event Type
    Death
    Date Received
    August 7, 1997
    Date of Event
    July 4, 1997
    Report Date
    August 7, 1997
    Manufacturer
    MEDTRONIC CARDIOPULMONARY DIV.
    Product Code
    DWE
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE MEDWATCH USER REPORT STATES "AFTER 10 DAYS OF TREATMENT FOR PULMONARY EMBOLISM, THE PT WAS PLACED ON ECMO. WITHIN TWO HRS THE OXYGENATOR BEGAN TO FOAM AND DECLINE IN PERFORMANCE. OXYGENATOR WAS CHANGED OUT. APPROXIMATELY TWO HOURS LATER, THE SECOND OXYGENATOR STARTED TO FAIL IN THE SAME MANNER. THE WHOLE SYSTEM WAS CHANGED OUT. DURING ECMO, IT WAS DISCOVERED THAT THE PT HAD HEPARIN ANTIBODIES AND HEPARIN INDUCED THROMBOCYTOPENIA. THE PT EXPIRED ON ECMO." IT WAS REPORTED THAT THE DEATH WAS NOT RELATED TO THE PRODUCTS OR CHANGE OUT OF THE CIRCUIT. ECMO IS AN OFF LABELED USE OF THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CUSTOM TUBING PACK CUSTOM TUBING PACK DWE MEDTRONIC CARDIOPULMONARY DIV. 2574 9401001249

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Death