BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TERUMO 7CM II COOLING AND HEATING SYSTEM

    MDR report key: 1931914 · Received November 30, 2010

    Report

    Report Number
    1828100-2010-02313
    Event Type
    Malfunction
    Date Received
    November 30, 2010
    Date of Event
    May 17, 2010
    Report Date
    June 9, 2010
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORP.
    Product Code
    DWC
    PMA / PMN Number
    K883603
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION IN PROGRESS, BUT NOT YET CONCLUDED.

    Description of Event or Problem · 1

    DURING ROUTINE TESTING OF THE DEVICE, THE USER REPORTED A WATER LEAK AT THE CARDIOPLEGIA PUMP OUTLET. NO OTHER DETAILS REGARDING THE NATURE OF THE EVENT WERE PROVIDED. SINCE THE EVENT OCCURRED DURING ROUTINE TESTING, THERE WAS NO PT INVOLVEMENT DURING THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TERUMO 7CM II COOLING AND HEATING SYSTEM HEATING COOLING SYSTEM DWC TERUMO CARDIOVASCULAR SYSTEMS CORP. 4415

    Patients

    Seq Age Sex Outcome Treatment
    1