BEUDAMED
    FDA Adverse Event Death Summary report: N

    MEDTRONIC, INC.

    MDR report key: 634322 · Received September 14, 2005

    Report

    Report Number
    MW1036603
    Event Type
    Death
    Date Received
    September 14, 2005
    Date of Event
    August 12, 2005
    Report Date
    September 2, 2005
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    DTZ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    NUMBER 12 FRENCH CANNULA PLACED IN IJ. PATIENT PLACED ON ECMO BYPASS. GOOD SATURATION (100%) INITIALLY. HOWEVER, MEMBRANE FAILED REQUIRING REPLACEMENT. PATIENT CODED DURING REPLACEMENT AND REQUIRED EPINEPHRINE AND OTHER RESUSCITATIVE MEDS. AFTER REPLACING MEMBRANE OXGENATOR AND REINITIATING ECMO, PATIENT DID NOT RESPOND AND EXPIRED DUE TO SEVERE PULMONARY HYPERTENSION AND CARDIO-RESPIRATORY FAILURE. (MEMBRANE FAILURE WAS IMMEDIATELY RECOGNIZED AND APPROPRIATELY HANDLED. PATIENT WAS BAGGED THROUGHOUT. IT IS BELIEVED THAT THE DEATH STEMS FROM THE MEDICAL CONDITION AS OPPOSED TO THE MEMBRANE FAILURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDTRONIC, INC. 0800 MEMBRANE OXYGENATOR DTZ MEDTRONIC, INC. 0800 *

    Patients

    Seq Age Sex Outcome Treatment
    1 7 DAY Death