BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    *

    MDR report key: 2220424 · Received August 8, 2011

    Report

    Report Number
    2220424
    Event Type
    Malfunction
    Date Received
    August 8, 2011
    Date of Event
    July 24, 2011
    Report Date
    August 8, 2011
    Manufacturer
    MAQUET
    Product Code
    DTL
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AZ, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE STOPCOCK ON THE EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO) WAS NOTED TO BE CLOTTED AND THEN LEAKING UPON ATTEMPTS TO FLUSH OUT THE CLOT INTO AN EMPTY SYRINGE. BLOOD WAS NOTED ON THE OUTSIDE OF STOPCOCK. AN AREA OF THE STOPCOCK WAS THE BIOHEAD CONE AND OXYGENATOR. THE STOPCOCK WAS CHANGED OUT WITH THE PERFUSIONIST AT THE BEDSIDE. THE PT WAS CLAMPED OUT FOR 20 SECONDS, AND THERE WAS NO CHANGE IN VITAL SIGNS. THE MFR RESPONSE WAS THE REP CAME TO THE FACILITY AND BROUGHT SAMPLES OF STOPCOCKS. THEY CHOSE ANOTHER STOPCOCK TO PUT INTO THE CIRCUITS. THE REP WILL BE REPLACING THE STOPCOCKS IN NEW CIRCUITS AND SENDING REPLACEMENT STOPCOCKS FOR CIRCUITS CURRENTLY IN STOCK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 * ECMO CIRCUIT STOPCOCK DTL MAQUET * 13035

    Patients

    Seq Age Sex Outcome Treatment
    1 12 YR