BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEPTUNE WASTE MANAGEMENT SYSTEM

    MDR report key: 1130483 · Received August 20, 2008

    Report

    Report Number
    MW5008042
    Event Type
    Malfunction
    Date Received
    August 20, 2008
    Date of Event
    August 14, 2008
    Report Date
    August 20, 2008
    Manufacturer
    STRYKER
    Product Code
    FYD
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TN, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    WHILE SURGEON USING NEPTUNE WASTE MANAGEMENT SYSTEM DURING AN ARTHROSCOPY, HE NOTED THAT THE UNIT WAS ALLOWING BACKFLOW OF SUCTION WASTE FLUID FROM THE NEPTUNE WASTE CANNISTER AND WAS ENTERING THE WOUND FROM THE SHAVER SUCTION. THE SHAVER WAS IN THE PT'S KNEE JOINT WHEN LOSS OF SUCTION WAS RECOGNIZED. EVERYTHING WAS IMMEDIATELY REMOVED. UPON PULLING THE SUCTION TUBING FREE FROM PORT, FLUID CONTINUED TO POUR FROM THE NEPTUNE FILTER PORT. WOUND WAS IRRIGATED WITH 9000CC OF ANTIBIOTIC IRRIGANT AND INTRAOP IV ANTIBIOTICS GIVEN. THIS MACHINE HAD 2 PREVIOUS PTS CONTAMINATED FLUIDS IN THE CANNISTER. PT WAS TREATED WITH HOME ANTIBIOTICS FOR 2 WEEKS, HIV/HEP PROPHYLAXIS AND LAB TESTING X 1 YEAR. STRYKER TESTING MACHINE, FOUND UNUSUAL PIECE OF PLASTIC IN CANNISTER. WE HAD ALSO NOT CHANGED MANIFOLD PROPERLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEPTUNE WASTE MANAGEMENT SYSTEM NEPTUNE WASTE MANAGEMENT SYSTEM FYD STRYKER B#050487

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR