BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TERUMO TCM II COOLING AND HEATING SYSTEM

    MDR report key: 1812112 · Received August 17, 2010

    Report

    Report Number
    1828100-2010-01151
    Event Type
    Malfunction
    Date Received
    August 17, 2010
    Date of Event
    July 17, 2010
    Report Date
    August 17, 2010
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORP.
    Product Code
    DWC
    PMA / PMN Number
    K883603
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN.

    Description of Event or Problem · 1

    DURING USE OF THE DEVICE FOR A CARDIOPULMONARY BYPASS PROCEDURE, THE USER REPORTED THE OSCILLATOR ON THE CENTRAL PROCESSING UNIT CIRCUIT BOARD WAS NOT FUNCTIONING AS EXPECTED. NO OTHER DETAILS REGARDING THE NATURE OF THE EVENT WERE PROVIDED. AN ALTERNATE DEVICE WAS EMPLOYED FOR THE PROCEDURE. THE USER REPORTED THE SURGICAL PROCEDURE WAS COMPLETED SUCCESSFULLY, AND THERE WERE NO ADVERSE CONSEQUENCES TO A PATIENT AS A RESULT OF 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. 4416

    Patients

    Seq Age Sex Outcome Treatment
    1