BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MPS 3 ND CONSOLE

    MDR report key: 17586072 · Received August 18, 2023

    Report

    Report Number
    MW5144788
    Event Type
    Injury
    Date Received
    August 18, 2023
    Date of Event
    August 14, 2023
    Report Date
    August 16, 2023
    Manufacturer
    QUEST MEDICAL, INC.
    Product Code
    DTR
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NY, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    DURING A CABG SURGERY MPS 3ND STOPPED GIVING CARDIOPLEGIA DESPITE MULTIPLE PREVIOUS SUCCESSFUL DOSES. SURGEON DECIDED TO REMOVE CROSS CLAMP AND FINISH THE LAST REMAINING ANASTOMOSIS BY UTILIZING THE OCTOPUS EVOLUTION STABILIZER VIA PUMP ASSIST. PATIENT CAME OFF BYPASS SMOOTHLY AND WITHOUT ADVERSE EVENT. MULTIPLE INADEQUATE INLET FILL ALARMS AS WELL AS UNABLE TO MAINTAIN FLOWRATE ALARMS (ERROR CODES 65-2082, 190-2093, 65-2083, 190-2093, 190-2093, 65-2083). THEY CHECKED FOR KINKS IN THE INLET LINE BUT EVERYTHING APPEARED NORMAL. UNIT SENT BACK TO COMPANY FOR EVALUATION & REPAIR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1035148 MPS 3 ND CONSOLE HEAT-EXCHANGER, CARDIOPULMONARY BYPASS DTR QUEST MEDICAL, INC. 5301000ND

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Female Required Intervention