BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXH 800 COULTER® CELLULAR ANALYSIS SYSTEM

    MDR report key: 2086154 · Received May 12, 2011

    Report

    Report Number
    1061932-2011-00402
    Event Type
    Malfunction
    Date Received
    May 12, 2011
    Date of Event
    April 11, 2011
    Report Date
    April 11, 2011
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    GKZ
    PMA / PMN Number
    K081930
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE FSE LOCATED THE FLUID CAUSING THE ANALYZER TO GIVE SOLENOID DISCONNECTED ERROR MESSAGES. THE FSE ALSO FOUND FLUID LEAKING FROM DISCONNECTED TUBING ON THE RED BLOOD COUNT (RBC) PUMP AND THE FSE REATTACHED THE TUBING. THE FSE POWERED ON THE ANALYZER AND SMELLED A STRONG BURNING ODOR BUT NO SMOKE WAS OBSERVED. THE FSE TRACED THE BURNING SMELL TO CHARRED COMPONENTS ON THE SOLENOID EXPANSION BOARD AND THE RELATED RIBBON CABLE. THE FSE REPLACED THE BOARD AND THE RIBBON CABLE. THE FSE THEN POWERED ON THE ANALYZER AND VERIFIED THE ANALYZER WITH NO FURTHER ISSUES SEEN. THE ROOT CAUSE WAS IDENTIFIED TO BE THE DISCONNECTED TUBING ON RBC PUMP WHICH LEAKED DILUENT AND CLENZ ONTO THE SOLENOID EXPANSION BOARD.

    Description of Event or Problem · 1

    WHILE A BECKMAN COULTER INC, (BCI) FIELD SERVICE ENGINEER (FSE) WAS SERVICING A CUSTOMER'S UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEM FOR "SOLENOID DISCONNECT" ERROR MESSAGES, THE FSE FOUND DRIED CLENZ AND DILUENT LEAK ON THE LEFT SIDE OF THE ANALYZER. THE FSE ALSO SMELLED SMOKE WHILE POWERING ON THE INSTRUMENT. THE LEAK WAS CONTAINED WITHIN THE INSTRUMENT PANEL AND THE CUSTOMER WAS NOT EXPOSED TO ANY LIQUID LEAK. NO EXPOSURE TO OPEN WOUNDS OR MUCOUS MEMBRANES. THE FSE WAS WEARING GLOVES, GOGGLES AND A LAB COAT WHILE TROUBLESHOOTING THE INSTRUMENT. NO USER WAS AFFECTED IN THIS EVENT AND NO ONE SOUGHT MEDICAL ATTENTION AND THE FIRE DEPARTMENT WAS NOT CALLED. ERRONEOUS RESULTS WERE NOT GENERATED IN THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL® DXH 800 COULTER® CELLULAR ANALYSIS SYSTEM HEMATOLOGY ANALYZER GKZ BECKMAN COULTER, INC. DXH 800 NA

    Patients

    Seq Age Sex Outcome Treatment
    1