BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONTINUOUS WAVE III ARTHROSCOPY PUMP

    MDR report key: 2802427 · Received October 24, 2012

    Report

    Report Number
    1220246-2012-00209
    Event Type
    Injury
    Date Received
    October 24, 2012
    Date of Event
    September 27, 2012
    Report Date
    September 28, 2012
    Manufacturer
    ARTHREX, INC.
    Product Code
    HRX
    PMA / PMN Number
    K024291
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    NO FURTHER PATIENT INFORMATION WAS PROVIDED AT THE TIME OF THIS REPORT OR MADE AVAILABLE IN RESPONSE TO FOLLOW-UP COMMUNICATION. NO ADDITIONAL ADVERSE CONSEQUENCES HAVE BEEN REPORTED FROM THIS EVENT. THIS DEVICE IS USED FOR TREATMENT. THE DEVICE WAS RECEIVED AND AN EVALUATION WAS CONDUCTED. THE COMPLAINT WAS NOT CONFIRMED. DEVICE HISTORY RECORD REVIEW REVEALED NOTHING RELEVANT TO THIS EVENT. VISUAL INSPECTION OF THE RETURNED PUMP REVEALED NO VISIBLE DAMAGES. FUNCTION TESTED THE PUMP WITH THE RETURNED TUBING AND NEW TUBING AND IT PERFORMED AS EXPECTED WITHOUT ANY MALFUNCTIONS. THE FACILITY RE-USED THE SAME TUBING ON THE SECOND AR-6475 PUMP. BASED ON THE INFORMATION PROVIDED AND DEVICE EVALUATION, THE MOST LIKELY CAUSE(S) OF THIS TYPE OF EVENT IS OR PROCEDURES RELATED TO THE SET-UP OF THE DEVICE AND TUBING DID NOT CONFORM TO INSTRUCTIONS PROVIDED. THE LABELING FOR THE DEVICE AND ASSOCIATED TUBING, INSTRUCTION MANUAL FOR THE PUMP AND TROUBLESHOOTING GUIDE FOR THE DEVICE CLEARLY OUTLINE THE PROPER SET-UP PROCEDURE AND SUFFICIENTLY WARN THE USER OF THE POTENTIAL CONSEQUENCES (EXTRAVASATION) IF INSTRUCTIONS FOR USE ARE NOT FOLLOWED. THE INSTRUCTIONS FOR USE FOR BOTH THE PUMP AND TUBING SETS CLEARLY WARN THE USER OF THE CONSEQUENCES OF NOT FOLLOWING THE INSTRUCTIONS FOR USE. ON THE TUBING PACKAGE, THERE IS A LABEL INSTRUCTING THE USER AS FOLLOWS: WARNING: DO NOT RECONNECT TUBING FOR ANY REASON. RECONNECTING TUBING THAT WAS DISCONNECTED MAY CAUSE PUMP PRESSURE MONITORING SYSTEM ERRORS WHICH MAY CAUSE EXTRAVASATION THAT COULD RESULT IN SERIOUS PATIENT INJURY. THIS IS THE FIRST COMPLAINT OF THIS TYPE FOR THIS PART/LOT COMBINATION. THE POTENTIAL CAUSE(S) OF THIS EVENT WILL BE COMMUNICATED TO THE EVENT REPORTER. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE STAFF CONNECTED PATIENT REDUCE TUBING AND HIT "RUN". THE PUMP RAN AT FULL SPEED AND STAFF SAID IT SOUNDED STRANGE (PRIOR TO CASE). THEY GOT ANOTHER AR-6475 PUMP AND USED SAME TUBING. THEY THEN TRIED A 2ND PUMP WHICH WAS SET AT 80/100 AND CONTINUOUSLY RAN AT MAXIMUM FLOW FOR REST OF CASE. THE PATIENT'S CASE WAS COMPLETED, BUT DUE TO PUMPS INABILITY TO REGULATE PRESSURE/FLOW ACCURATELY, 9000ML OF FLUID WAS INSTILLED IN KNEE IN LESS THAN FOURTEEN MINUTES INTO THE CASE. THIS CAUSED THE PATIENT TO POSSIBLY HAVE COMPARTMENT SYNDROME AND HAD TO TRANSFER TO THE INTENSIVE-CARE UNIT. PATIENT WAS RELEASED FROM ICU ON (B)(6) 2012, SHE HAS A LITTLE NUMBNESS IN HER THIGH DUE TO THE FLUID. PATIENT IS FINE. NO COMPARTMENT SYNDROME WAS PRESENT. CASE: RIGHT KNEE SCOPE. ACCOUNT CANNOT STATE WHICH PUMP WAS USED IN THE CASE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Other AR-6475 PUMP, SERIAL # (B)(4)| AR-6215, TUBING ADAPTER, Y, DOUBLE SPIKED.| AR-6411, REDEUCE PUMP TUBING, LOT #8152