BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TERUMO TCM II COOLING AND HEATING SYSTEM

    MDR report key: 3221855 · Received July 9, 2013

    Report

    Report Number
    1828100-2013-00650
    Event Type
    Malfunction
    Date Received
    July 9, 2013
    Date of Event
    June 18, 2013
    Report Date
    June 18, 2013
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEM CORP
    Product Code
    DWC
    PMA / PMN Number
    K883603
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE BIOMED MEASURED THE FLOW IN "LARGE TANK MODE" AND IT MEASURED AT 4.2 LITERS PER MINUTE AT HIGH SPEED. HE SAID IN "LARGE TO SMALL" MODE, IT MEASURED 17 LITERS PER MINUTE. THE BIOMED ASKED TECHNICAL SUPPORT IF THE HANSEN FITTINGS COULD MAKE THAT MUCH OF A DIFFERENCE. TECHNICAL SUPPORT TOLD THE BIOMED, THAT IF THEY ARE PARTIALLY CLOGGED IT WOULD AFFECT THE FLOW. THE TRAINED BIOMED REPLACED THE HANSEN FITTINGS AND THE FLOW ON THE COOLER HEATER UNIT WAS NOW NORMAL. THE OLD FITTINGS WERE DISCARDED AFTER BEING REPLACED, AND NO PARTS CAN BE RETURNED TO THE MANUFACTURER FOR ANALYSIS. IF ADDITIONAL INFO BECOMES AVAILABLE ON THIS COMPLAINT THAT WOULD ALTER THE FACTS AND/OR CONCLUSION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY.

    Description of Event or Problem · 1

    THE USER FACILITY'S BIOMEDICAL ENGINEER (BIOMED) REPORTED THAT DURING PREVENTATIVE MAINTENANCE (PM) OF THE DEVICE, THE CARDIOPLEGIA WAS NOT FLOWING AS IT WOULD NORMALLY BE IN "LARGE TANK MODE". SINCE THE EVENT OCCURRED DURING PREVENTATIVE MAINTENANCE, THERE WAS NO PT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    312835 TERUMO TCM II COOLING AND HEATING SYSTEM DWC TERUMO CARDIOVASCULAR SYSTEM CORP 4415

    Patients

    Seq Age Sex Outcome Treatment
    1