BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MAQUET HEATER COOLER UNIT HCU 30

    MDR report key: 4280275 · Received November 26, 2014

    Report

    Report Number
    8010762-2014-01217
    Event Type
    Injury
    Date Received
    November 26, 2014
    Date of Event
    June 21, 2012
    Report Date
    June 23, 2012
    Manufacturer
    MAQUET CARDIOPULMOARY AG
    Product Code
    DWC
    PMA / PMN Number
    K031544
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PER SERVICE REPORT (B)(4), THE REPORTED EVENT WAS NOT REPRODUCED, HOWEVER, THE 3 WAY VALVE AND VALVE ACTUATOR WERE REPLACED. THE UNIT WAS TESTED TO FACTORY SPECIFICATIONS AND PASSED ALL TESTS. THE REPLACED PARTS WERE SENT TO MCP (B)(4) FOR EVALUATION AND PER ANALYSIS REPORT (B)(4) THE ACTUATOR AND VALVE WERE FUNCTIONING CORRECTLY, HOWEVER, DURING THE ASSEMBLY OF THE HCU 30 3 DISTANCE WASHERS WERE NEEDED IN THE ADAPTOR HOUSING. THIS IS REQUIRED TO LOOSEN THE CONTACT BETWEEN THE BUNG OF THE EMO 1 AND THE BUNG OF THE 3 WAY VALVE. (B)(4).

    Description of Event or Problem · 1

    ON (B)(6) 2012 AT (B)(6), IT WAS REPORTED THE HEATER COOLER UNIT 30 (HCU 30) SERIAL NUMBER (B)(4) WOULD NOT REWARM THE PATIENT. THE PERFUSIONIST HAD TO KEEP THE PATIENT ON BYPASS FOR AN ADDITIONAL 20 MINUTES WHILE THE DEVICE WAS REPLACED WITH ANOTHER. THE PATIENT WAS STABLE POST COMPLETION OF THE PROCEDURE. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    768109 MAQUET HEATER COOLER UNIT HCU 30 CONTROLLER, TEMPERATURE, CPB DWC MAQUET CARDIOPULMOARY AG 70103.4371

    Patients

    Seq Age Sex Outcome Treatment
    1 Congenital Anomaly