BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TERUMO TCM II COOLING AND HEATING SYSTEM

    MDR report key: 3060646 · Received April 5, 2013

    Report

    Report Number
    1828100-2013-00334
    Event Type
    Malfunction
    Date Received
    April 5, 2013
    Date of Event
    March 1, 2013
    Report Date
    March 18, 2013
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEM CORP
    Product Code
    DWC
    PMA / PMN Number
    K883603
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING USE OF THE DEVICE FOR A CARDIOPULMONARY BYPASS PROCEDURE, THE COOLER HEATER UNIT WAS LEAKING. THE DEVICE WAS NOT CHANGED OUT, AS THE USER COMPLETED THE SURGERY WITH THIS UNIT. THE SURGICAL PROCEDURE WAS COMPLETED SUCCESSFULLY, AND THERE WERE NO DELAYS, NO BLOOD LOSS OR NO ADVERSE CONSEQUENCES TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    141728 TERUMO TCM II COOLING AND HEATING SYSTEM DWC TERUMO CARDIOVASCULAR SYSTEM CORP 4415

    Patients

    Seq Age Sex Outcome Treatment
    1