BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    *

    MDR report key: 1264383 · Received December 7, 2008

    Report

    Report Number
    1264383
    Event Type
    Malfunction
    Date Received
    December 7, 2008
    Date of Event
    October 30, 2008
    Report Date
    December 7, 2008
    Manufacturer
    GISH BIOMEDICAL, INC
    Product Code
    DWB
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    IN THE PROCESS OF USING THE ECMO BLOOD TUBING, THE TUBING/CIRCUIT WALKED (MOVED) IN THE PUMP HOUSING AND AS A RESULT THE PUMP WENT INTO AN UNRECOVERABLE ALARM. THE PUMP WAS HAND CRANKED AND A DIFFERENT PUMP WAS REQUESTED FROM THE ECMO OFFICE. THE MALFUNCTIONING PUMP WAS REPLACED WITH THE ARRIVAL OF A REPLACEMENT PUMP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 * PUMP, CARDIOVASCULAR, ECMO DWB GISH BIOMEDICAL, INC 043605000 *

    Patients

    Seq Age Sex Outcome Treatment
    1 2 MO