BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAQUET HEATER COOLER UNIT HCU30

    MDR report key: 4927471 · Received July 21, 2015

    Report

    Report Number
    8010762-2015-00579
    Event Type
    Malfunction
    Date Received
    July 21, 2015
    Date of Event
    February 26, 2013
    Report Date
    March 5, 2013
    Manufacturer
    MAQUET CARDIOPULMONARY AG
    Product Code
    DWC
    PMA / PMN Number
    K031544
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    "MAQUET MEDICAL SYSTEM, USA SUBMITS THIS REPORT ON BEHALF OF THE LEGAL MANUFACTURER OF THE DEVICE MAQUET CARDIOPULMONARY (B)(4). THE DEVICE WAS EVALUATED BY THE SSU AND THE COMPRESSOR WAS FOUND TO BE DEFECTIVE AND WAS REPLACED. (B)(4)."

    Description of Event or Problem · 1

    "ON (B)(6) 2013 THE SSU REPRESENTATIVE FOR MAQUET IN (B)(6) REPORTED THAT WITH CARDIOPLEGIA SIDE OF THE HCU 30 SERIAL NUMBER 100155 AT 8ºC AND PATIENT SIDE AT 38 ºC, THE TANK TEMPERATURE WAS AT 3ºC. AFTER 15 TO 30 MIN COMPRESSOR GOT TURNED OFF REGARDLESS THE TANK TEMPERATURE. THE TANK TEMPERATURE BEGAN TO RISE AS DID THE CARDIOPLEGIA SIDE WATER TEMPERATURE AND COULD NOT BE REGULATED. THERE WAS NO CHANGE TO THE PATIENT SIDE TEMPERATURE AND IT CONTINUED TO BE REGULATED. (B)(4)."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    472442 MAQUET HEATER COOLER UNIT HCU30 CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS DWC MAQUET CARDIOPULMONARY AG UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1