BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TERUMO TCM II COOLING AND HEATING SYSTEM

    MDR report key: 2961557 · Received February 11, 2013

    Report

    Report Number
    1828100-2013-00101
    Event Type
    Malfunction
    Date Received
    February 11, 2013
    Date of Event
    January 15, 2013
    Report Date
    January 16, 2013
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS 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

    Description of Event or Problem · 1

    AFTER USE OF THE DEVICE FOR A CARDIOPULMONARY BYPASS PROCEDURE, THE USER REPORTED WHEN THE UNIT WAS IN "DEFROST MODE", THE MAIN MOTOR WOULD SHUT OFF. THERE WAS NO FLOW OVER THE ICE BANK WITH A "PUMP NOT PRIMED" INDICATION MESSAGE. THIS OCCURED AFTER SURGERY WHILE THE UNIT WAS BEING DEFROSTED. THERE WERE NO REPORTED ADVERSE CONSEQUENCES TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    59996 TERUMO TCM II COOLING AND HEATING SYSTEM DWC TERUMO CARDIOVASCULAR SYSTEMS CORP. 4415

    Patients

    Seq Age Sex Outcome Treatment
    1