BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TERUMO TCM II COOLING AND HEATING SYSTEM

    MDR report key: 3832578 · Received March 27, 2014

    Report

    Report Number
    1828100-2014-00203
    Event Type
    Malfunction
    Date Received
    March 27, 2014
    Date of Event
    March 5, 2014
    Report Date
    March 6, 2014
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEM CORP
    Product Code
    DWC
    PMA / PMN Number
    K883603
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    WHEN THE FSR WENT OUT FOR REPAIR HE FOUND THAT THE HOSE WAS COLLAPSING IN THIGH SPEED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT CARDIOPLEGIA FLOW WAS NOT WORKING IN SPEED 3 FROM LARGE TO SMALL TANK ON THE COOLER HEATER UNIT. NO OTHER DETAILS REGARDING THE NATURE OF THIS EVENT WERE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    179508 TERUMO TCM II COOLING AND HEATING SYSTEM TCM II COOLING AND HEATING SYSTEM DWC TERUMO CARDIOVASCULAR SYSTEM CORP 4415

    Patients

    Seq Age Sex Outcome Treatment
    1