BEUDAMED
    FDA Adverse Event Other Summary report: N

    *

    MDR report key: 174040 · Received June 24, 1998

    Report

    Report Number
    MW1014064
    Event Type
    Other
    Date Received
    June 24, 1998
    Date of Event
    June 1, 1998
    Report Date
    June 15, 1998
    Manufacturer
    QUEST MEDICAL, INC.
    Product Code
    DWB
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    FOLLOWING INITIATION OF CARDIOPULMONARY BYPASS THE MPS CARDIOPLEGIA SYS WAS PRIMED WITH THE PT'S BLOOD. UPON DELIVERY OF CARDIOPLEGIA, A LEAK WAS NOTICED AT THE JUNCTION OF THE BLOOD COMPARTMENT AND THE HEATER/COOLER WATER COIL. THE LEAK WAS ISOLATED WITHIN THE WATER COMPONENT (WHICH IS NON-STERILE).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 * CARDIOPLEGIA DELIVERY SYSTEM DWB QUEST MEDICAL, INC. MPS 8610

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Other