BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TERUMO TCM II COOLING AND HEATING SYSTEM

    MDR report key: 2961559 · Received February 11, 2013

    Report

    Report Number
    1828100-2013-00102
    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

    Additional Manufacturer Narrative · 1

    EVALUATION IS IN PROGRESS, BUT NOT YET CONCLUDED.

    Description of Event or Problem · 1

    AFTER USE OF THE DEVICE FOR A CARDIOPULMONARY BYPASS PROCEDURE, THE USER REPORTED WHEN IN "COOL DOWN MODE", THERE WAS WATER FLOWING OVER THE ICE TANK. WHEN THE FIELD SVC REP (FSR) CLAMPED OFF THE OUTPUT LOOP, THERE SHOULD BE NO FLOW. HOWEVER, THERE WAS STILL FLOW. 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
    59916 TERUMO TCM II COOLING AND HEATING SYSTEM DWC TERUMO CARDIOVASCULAR SYSTEMS CORP. 4415

    Patients

    Seq Age Sex Outcome Treatment
    1