BEUDAMED
    FDA Adverse Event Summary report: N

    V-V ECMO

    MDR report key: 2960626 · Received February 7, 2013

    Report

    Report Number
    MW5028948
    Date Received
    February 7, 2013
    Date of Event
    May 13, 2012
    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 AWAITING LUNG TX PLACED ON V-V ECMO (B)(6) 2012 AT 2042. ON (B)(6) 2012 AN ADDITIONAL DRAINAGE CANNULA WAS ADDED TO THE FEMORAL VEIN TO AUGMENT VENOUS RETURN DUE TO INCREASED PULMONARY DEMANDS. ON (B)(6) 2012 CIRCUIT PACK #(B)(4), LOT # 12088719 WAS CHANGED DUE TO NOISY PUMP HEAD. ON (B)(6) 2012 HEAD LOT# 11872464 CHANGED DUE TO SUDDEN AND ABRUPT DROP IN FLOW. PT EVENTUALLY REMOVED FROM TX LIST AND TERMINALLY WEANED ON (B)(6) 2012 AT 0510. (B)(4). EVENT ABATED AFTER USE STOPPED OR DOSE REDUCED? YES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    51403 V-V ECMO DTZ MEDTRONIC
    51404 CANNULA DWF MEDTRONIC
    51405 CIRCUIT PACK DWB MEDTRONIC 12088719
    51491 PUMP HEAD DWF MEDTRONIC 11872464

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention