BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MPS2

    MDR report key: 3944607 · Received July 14, 2014

    Report

    Report Number
    MW5037285
    Event Type
    Injury
    Date Received
    July 14, 2014
    Date of Event
    July 10, 2014
    Report Date
    July 11, 2014
    Manufacturer
    QUEST MEDICAL INC
    Product Code
    DTR
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IL, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    CARDIO-PULMONARY BYPASS RUNNING. IN THE MIDDLE OF THE THIRD DOSE OF CARDIOPLEGIA, THE QUEST MPS2 DELIVERY SYSTEM MALFUNCTIONED. ERROR CODE ON SCREEN. SYSTEM POWERED DOWN AND BACK UP WITH SAME ERROR CODE. DID THIS 4 TIMES BEFORE REPLACING SYSTEM COMPONENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    410123 MPS2 MPS2 DTR QUEST MEDICAL INC MPS2

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Required Intervention