BEUDAMED
    FDA Adverse Event Other Summary report: N

    PUMP, CONTINUOUS WAVE III

    MDR report key: 1069319 · Received July 1, 2008

    Report

    Report Number
    1220246-2008-00123
    Event Type
    Other
    Date Received
    July 1, 2008
    Date of Event
    June 2, 2008
    Report Date
    June 2, 2008
    Manufacturer
    ARTHREX, INC.
    Product Code
    HRX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE ARTHROSCOPIC PUMP AND TUBING USED IN THE CASE WERE NOT RELEASED TO ARTHREX INC. FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NOTHING RELEVANT TO THIS EVENT. THE DIRECTIONS FOR USE (DFU) FOR THE PUMP TUBING STATES "PROPER USE OF THIS DEVICE REQUIRES THE ESTABLISHMENT OF ADEQUATE FLUID OUTFLOW AND MONITORING OF THE SURGICAL FIELD." THE TUBING DFU ALONG WITH THE PUMP TROUBLESHOOTING GUIDE INSTRUCT THE USER TO "...CAREFULLY MONITOR AND MAINTAIN FLUID OUTFLOW AND ASSESS THE PATIENT REGULARLY TO AVOID EXTRAVASATION OR ANY OTHER ADVERSE PATIENT CONDITION." THE CAUSE OF THE COMPLAINANTS EVENT COULD NOT BE DETERMINED WITHOUT EVALUATION OF THE PUMP AND TUBING INVOLVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A FEW MINUTES INTO THE CASE, THE PATIENT'S KNEE AND QUADRICEPS DISTENDED. SURGEON NOTICED THE CHAMBER OF THE PUMP TUBING CONNECTED TO THE SENSOR, COMPLETELY FULL OF FLUID AND THE PUMP WAS RUNNING WITH NO OUTFLOW OF FLUID FROM THE PATIENT. THE SURGEON COULD NOT FLEX THE PATIENT'S KNEE AND STOPPED THE CASE. THE PATIENT CONDITION RESOLVED NATURALLY AFTER THE PROCEDURE. THE PATIENT WAS RE-INTERVENED ONE WEEK LATER ON (B) (6) 2008. NO FURTHER PATIENT INFORMATION IS AVAILABLE AND NO ADDITIONAL ADVERSE CONSEQUENCES HAVE BEEN REPORTED FROM THIS EVENT. THIS DEVICE IS USED FOR TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PUMP, CONTINUOUS WAVE III ARTHROSCOPIC PUMP HRX ARTHREX, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention AR-6410/LOT #003589 (PUMP TUBING)