BEUDAMED
    FDA Adverse Event Other Summary report: N

    PUMP, CONTINUOUS WAVE III

    MDR report key: 1001408 · Received February 20, 2008

    Report

    Report Number
    1220246-2008-00037
    Event Type
    Other
    Date Received
    February 20, 2008
    Date of Event
    October 3, 2007
    Report Date
    January 23, 2008
    Manufacturer
    ARTHREX, INC.
    Product Code
    HRX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER MADE THE STATEMENT THAT THE PRESSURE INCREASED EXCESSIVELY DURING THE SURGERY. THERE IS NO CONFIRMATION OF THIS AS THE CUSTOMER ALSO INDICATED THE PUMP MONITOR DID NOT DISPLAY THE INCREASE AND MADE NO MENTION OF AN INDEPENDENT MONITOR. DURING THE INVESTIGATION IT WAS DETERMINED THAT INTERNATIONAL AFFILIATE HAD PURCHASED THIS PUMP DIRECTLY FROM THE VENDOR. THE PUMP WAS EVALUATED BY OUR AFFILIATE AND NO PROBLEMS WERE FOUND, OUR INTERNATIONAL AFFILIATE ALSO INDICATES THAT THE PUMP IS STILL IN USE BY THE HOSP WITHOUT ANY FURTHER ISSUES. THE TUBING INVOLVED WAS DISCARDED BY THE HOSP. EVALUATION OF SIMILAR EVENTS INDICATE THIS TYPE OF EVENT IS TYPICALLY RELATED TO IMPROPER PUMP/TUBING SETUP. HOWEVER, THE CAUSE OF THIS EVENT COULD NOT BE DETERMINED FROM THE INFO AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PRESSURE INCREASED EXCESSIVELY DURING AN ARTHROSCOPY SURGERY. THE INCREASE IN THE PRESSURE DID NOT SHOW AND THE ALARM DID NOT START. THE PT SUFFERED FEMORAL EDEMA. FURTHER INFO RECEIVED ON 2/14/08 INDICATES THE PT WAS ADMINISTERED VOLTAREN AND LOCAL KRYOTHERAPY ALONG WITH LYMPH-DRAINAGE TO RESOLVE THE CONDITION. THE SURGICAL PROCEDURE WAS A MENISCECTOMY, SYNOVECTOMY. THE PT IS REPORTED TO BE FULLY RECOVERED. 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/UNK