BEUDAMED
    FDA Adverse Event Summary report: N

    CONTINUOUS WAVE III

    MDR report key: 878895 · Received June 21, 2007

    Report

    Report Number
    878895
    Date Received
    June 21, 2007
    Date of Event
    May 17, 2007
    Report Date
    June 21, 2007
    Manufacturer
    ARTHREX ARTHROSCOPY INSTRUMENTS, INC.
    Product Code
    HRX
    Report Source
    User Facility report
    Reporter Location
    MI, US

    Narratives

    Description of Event or Problem · 1

    DURING A RIGHT KNEE ARTHROSCOPY, THE ARTHREX WATER PUMP BEGAN ALARMING "PRESSURE FAULT." THE CIRCULATING NURSE STOPPED THE PUMP AND BEGAN LOOKING AT THE TROUBLESHOOTING PROCEDURE. THE NURSE LOOKED AT THE FLUID, AND IT WAS ADEQUATE; SHE THEN TOOK THE SUCTION TUBING FROM THE CANISTER OFF, AND TRIED TO RESTART THE PUMP. THE PUMP SPUN VERY FAST AND AGAIN STATED "PRESSURE FAULT." THE NURSE THEN RECONNECTED THE SUCTION AS FLUID WAS COMING OUT OF THE KNEE FROM THE FIELD. ALL THE CLAMPS ALONG THE TUBING WERE CHECKED, AND ALL WERE FOUND TO BE OPEN. THE PUMP WAS RESTARTED, AND AGAIN IT WAS SPINNING REALLY FAST, SO THE PUMP WAS STOPPED AGAIN. AT THIS POINT, THE SURGEON STATED THAT THE PATIENT'S THIGH WAS VERY HARD AND HE WAS HAVING DIFFICULTY BENDING THE KNEE. THE SCOPE WAS REMOVED FROM THE KNEE AND THE TOURNIQUET WAS RELEASED AFTER ONLY 24 MIN OF BEING INFLATED. THE SURGEON THEN APPLIED PRESSURE TO TRY TO REDUCE THE SWELLING. THE NURSE CONTINUED TO TROUBLESHOOT THE PUMP BY REQUESTING A NEW ARTHREX PUMP. THE TUBING WAS CHANGED OVER TO THE NEW MACHINE AND RESTARTED. AFTER ONE MINUTE THE SAME "PRESSURE FAULT" ERROR OCCURRED, HOWEVER, THIS TIME THE SCOPE WAS NOT IN THE KNEE. THE TUBING WAS CHANGED ON THE NEW PUMP, AND THE PUMP WAS RESTARTED. EVERYTHING SEEMED TO CHECK OUT AND WORK CORRECTLY, AND THE CASE WAS COMPLETED. UNFORTUNATELY THE ORIGINAL TUBING USED WAS DISCARDED AFTER THE CASE WAS FINISHED. THIS IS AT LEAST THE THIRD TIME A PROBLEM OF THIS NATURE HAS HAPPENED AT OUR FACILITY. THIS SYSTEM REQUIRES THAT THE EXACT SETUP STEPS BE FOLLOWED PRECISELY IN THE CORRECT ORDER FOR THE PUMP TO FUNCTION PROPERLY. IF THE BALLOON INSIDE THE CYLINDER IS INADVERTENTLY COLLAPSED, PRESSURE CHANGES WILL NOT BE CORRECTLY DETECTED. THE BALLOON MAY BECOME COLLAPSED BY LEAVING THE TUBING CLAMPS ON WHEN STARTING THE PUMP, OR BY SPIKING THE FLUID BAGS BEFORE INSERTING THE DISPOSABLE PRESSURE SENSING COMPONENTS. IF THE TUBING IS DISCONNECTED AND THEN RECONNECTED, OR IF THE SAME TUBING IS USED ON A DIFFERENT MACHINE, THIS WILL NOT REPAIR THE PRESSURE CALIBRATION PROBLEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONTINUOUS WAVE III PUMP, ARTHROSCOPIC HRX ARTHREX ARTHROSCOPY INSTRUMENTS, INC. AR-6475 *
    2 TUBING, ARTHROSCOPIC PUMP --- ARTHREX ARTHROSCOPY INSTRUMENTS, INC. AR-6410 *

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR