BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TERUMO TCM II COOLING AND HEATING SYSTEM

    MDR report key: 4122505 · Received September 22, 2014

    Report

    Report Number
    1828100-2014-00765
    Event Type
    Malfunction
    Date Received
    September 22, 2014
    Date of Event
    August 31, 2014
    Report Date
    August 31, 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 TECHNICAL SUPPORT TO THE FIELD SERVICE REP (FSR): "IT SOUNDS LIKE THE MEMBRANE PANEL OR ONE OF THE DISPLAY BOARDS MAY BE SHORTED. YOU CAN OHM THE MEMBRANE PANEL FOR SHORTS AFTER DISCONNECTING IT FROM THE BOARDS. IF IT IS NOT EITHER THE MEMBRANE PANELS OR DISPLAY BOARDS, IT COULD BE THE COMPUTER CARD."

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE USE OF THE DEVICE FOR A NON-CLINICAL ACTIVITY, THE PERFUSIONIST (CCP) WAS SANITIZING THE COOLER HEATER UNIT LAST EVENING. THE UNIT WORKED AT FIRST AND TEN MINUTES LATER, HE WAS UNABLE TO MAKE ANY MODE SELECTIONS ON THE CONTROL PANEL. THE CCP SAID EVEN THE CARDIOPLEGIA SELECTIONS WOULD NOT WORK. THERE WAS NO PT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    587651 TERUMO TCM II COOLING AND HEATING SYSTEM TERUMO TCM II COOLING AND HEATING SYSTEM DWC TERUMO CARDIOVASCULAR SYSTEMS CORP. 4415

    Patients

    Seq Age Sex Outcome Treatment
    1