BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONTINUOUS WAVE III ARTHROSCOPY PUMP

    MDR report key: 1843907 · Received September 24, 2010

    Report

    Report Number
    1220246-2010-00184
    Event Type
    Injury
    Date Received
    September 24, 2010
    Date of Event
    August 1, 2010
    Report Date
    September 1, 2010
    Manufacturer
    ARTHREX, INC.
    Product Code
    HRX
    PMA / PMN Number
    K024291
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT'S DEMOGRAPHICS (AGE AT TIME OF EVENT, DATE OF BIRTH, GENDER, WEIGHT) WERE REQUESTED BUT NOT PROVIDED. 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 REQUESTED FOR EVALUATION BUT WAS NOT RETURNED, THEREFORE THE COMPLAINANT'S EVENT COULD NOT BE VERIFIED. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED FROM THE INFORMATION AVAILABLE AND WITHOUT DEVICE EVALUATION. DEVICE HISTORY RECORD REVEALED NOTHING RELEVANT TO THIS EVENT. BASED ON THE INFORMATION PROVIDED, THE MOST LIKELY CAUSE(S) OF THIS TYPE OF EVENT IS FROM A REVIEW OF SIMILAR EVENTS REPORTED TO ARTHREX, WHERE PUMP AND TUBING WERE RETURNED FOR EVALUATION AND INDICATES THAT 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. THIS IS THE FIRST COMPLAINT OF THIS TYPE FOR THIS PART/SERIAL COMBINATION. THE POTENTIAL CAUSES OF THIS EVENT ARE BEING COMMUNICATED TO THE EVENT REPORTER. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SUBMITTED. CUSTOMER WILL NOT RETURN THE DEVICE.

    Description of Event or Problem · 1

    THE PUMP WAS RUNNING CONTINUOUSLY. IT WAS REPORTED THAT 8.9 LITERS OF WATER LEAKED INTO THE PATIENT'S BODY. THE SURGEON FOUND SWELLING UNDER THE BELLY AREA AFTER THE SURGERY WAS FINISHED. THE SURGEON USED THE PUMP AT 40 MMHG OF PRESSURE AND 60% OF FLOW RATE. THE PATIENT GOT EDEMA IN LOWER ABDOMEN AND HAD TO HAVE ANOTHER SURGERY FOR REMOVING THE EDEMA. NO FURTHER PATIENT OR EVENT INFORMATION WAS PROVIDED AT THE TIME THIS EVENT WAS REPORTED.

    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 Other AR-6410, MAIN PUMP TUBING| AR-6411, REDEUCE PUMP TUBING