BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TERUMO TCM II COOLING AND HEATING SYSTEM

    MDR report key: 3012962 · Received March 1, 2013

    Report

    Report Number
    1828100-2013-00198
    Event Type
    Malfunction
    Date Received
    March 1, 2013
    Date of Event
    February 7, 2013
    Report Date
    February 7, 2013
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORP.
    Product Code
    DWC
    PMA / PMN Number
    K883603
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING SET-UP OF THE DEVICE FOR A CARDIOPULMONARY BYPASS PROCEDURE, THE COOLER HEATER UNIT HAD VERY LOW FLOW. THE DEVICE WAS NOT CHANGED OUT, AS THE UNIT STILL FUNCTIONED AND THEY HAVE BEEN USING FOR SURGERY. THE SURGICAL PROCEDURE WAS COMPLETED SUCCESSFULLY, AND THERE WERE ON DELAYS, NO BLOOD LOSS OR NO ADVERSE CONSEQUENCES TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    90486 TERUMO TCM II COOLING AND HEATING SYSTEM DWC TERUMO CARDIOVASCULAR SYSTEMS CORP. 164925

    Patients

    Seq Age Sex Outcome Treatment
    1