BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TERUMO TCM II COOLING AND HEATING SYSTEM

    MDR report key: 1880399 · Received October 15, 2010

    Report

    Report Number
    1828100-2010-01754
    Event Type
    Malfunction
    Date Received
    October 15, 2010
    Date of Event
    September 16, 2010
    Report Date
    October 15, 2010
    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
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL IN PROGRESS, BUT NOT YET CONCLUDED.

    Description of Event or Problem · 1

    DURING PREVENTATIVE MAINTENANCE OF THE DEVICE, THE USER REPORTED THE HEATER COOLER DEMONSTRATED POOR FLOW DURING COOL DOWN AND REWARM. THE USER REPORTED THAT THE VALVE 2 WAS REPLACED. SINCE THE EVENT OCCURRED DURING PREVENTATIVE MAINTENANCE OF THE DEVICE, THERE WAS NO PT INVOLVEMENT DURING THIS EVENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1