BEUDAMED
    FDA Adverse Event Injury Summary report: N

    V-V ECMO

    MDR report key: 2960619 · Received February 7, 2013

    Report

    Report Number
    MW5028946
    Event Type
    Injury
    Date Received
    February 7, 2013
    Date of Event
    September 6, 2012
    Report Date
    February 7, 2013
    Manufacturer
    MEDTRONIC
    Product Code
    DTZ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT WITH A TRAUMATIC EMERGENT PNEUMONECTOMY LATER PLACED ON V-V ECMO ON (B)(6) 2012 AT 1947. COMPLETE CIRCUIT CHANGE ON (B)(6) 2012 AT 0937 DUE TO LARGE AMOUNTS CLOTS THROUGHOUT CIRCUIT. PUMP HEAD WAS NOTED TO HAVE VISIBLE CLOT ON INLET PIN, AS WELL AS CLOT THROUGHOUT THE OXYGENATOR AND CIRCUIT. PT EVENTUALLY TERMINALLY WEANED ON (B)(6) 2012 AT 0548. (B)(4). EVENT ABATED AFTER USE STOPPED OR DOSE REDUCED? YES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    52132 V-V ECMO DTZ MEDTRONIC UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention