BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TERUMO TCM II COOLING AND HEATING SYSTEM

    MDR report key: 4093166 · Received August 21, 2014

    Report

    Report Number
    1828100-2014-00682
    Event Type
    Malfunction
    Date Received
    August 21, 2014
    Date of Event
    July 1, 2014
    Report Date
    July 30, 2014
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS 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

    Additional Manufacturer Narrative · 1

    PER THE CUSTOMER, THERE WERE NO LEAKS, LIGHTS OR ANY HEATING/COOLING PROBLEMS WITH THE UNIT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING SET-UP/PRIMING OF THE DEVICE FOR A CARDIOPULMONARY BYPASS PROCEDURE, THE COOLER HEATER UNIT'S ICE BLOCK WAS TOO LARGE. THE BLOCK WAS SO BIG THAT WATER COULD NOT CIRCULATE THROUGH THE SYSTEM AND THEY COULD NOT AUTOMATICALLY DEFROST THE BLOCK. AS A RESULT, AN ALTERNATIVE DEVICE WAS EMPLOYED. THE SURGICAL PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WERE NO DELAYS, NO BLOOD LOSS, AND NO ADVERSE CONSEQUENCES TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    506878 TERUMO TCM II COOLING AND HEATING SYSTEM DWC TERUMO CARDIOVASCULAR SYSTEMS CORP. 4415

    Patients

    Seq Age Sex Outcome Treatment
    1