BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TERUMO TCM II COOLING AND HEATING SYSTEM

    MDR report key: 2160419 · Received June 20, 2011

    Report

    Report Number
    1828100-2011-01715
    Event Type
    Malfunction
    Date Received
    June 20, 2011
    Date of Event
    May 20, 2011
    Report Date
    June 20, 2011
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORP.
    Product Code
    DWC
    PMA / PMN Number
    K883603
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    UPON INSTALLATION OF THE DEVICE, THE USER REPORTED THAT THE DEVICE BOOTED UP, BUT THERE WAS NO REACTION WHEN THE COOL DOWN AND CARDIOPLEGIA WERE ACTIVATED. INVESTIGATION AT USER FACILITY REVEALED AN IMPROPER CONNECTION OF CONNECTIONS 13 AND 14. THE DEVICE WAS REPAIRED AT THE USER FACILITY AND WILL NOT BE RETURNED. SINCE THE EVENT OCCURRED UPON INSTALLATION, THERE WAS NO PATIENT 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