BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXH 800 COULTER® HMX CELLULAR ANALYSIS SYSTEM

    MDR report key: 2262765 · Received September 23, 2011

    Report

    Report Number
    1061932-2011-01506
    Event Type
    Malfunction
    Date Received
    September 23, 2011
    Date of Event
    August 24, 2011
    Report Date
    August 24, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    GKZ
    PMA / PMN Number
    K081930
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A FIELD SERVICE ENGINEER (FSE) WENT ON-SITE (B)(6) 2011 AND NOTED THAT THE LEAK WAS RELATED TO THE NRBC MIXING CHAMBER BEING CLOGGED WHICH MADE IT OVERFLOW (BLOOD, DILUENT AND CELL LYSE ARE THE FLUIDS PRESENT IN THE NRBC MIXING CHAMBER). FSE TOOK IT OUT, UNCLOGGED IT WITH A SYRINGE AND PLACED IT BACK INTO PLACE AND TESTED THAT IT WAS DRAINING PROPERLY AND VERIFIED INSTRUMENT PERFORMANCE. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BEC) STATING THAT THEY WERE SEEING A BROWNISH FLUID LEAK ON THE UNICEL DXH 800 COULTER HMX CELLULAR ANALYSIS SYSTEM AND THE BOTTOM OF THE INSTRUMENT WAS FLOODED. THE USER WAS WEARING PERSONAL PROTECTIVE EQUIPMENT (PPE). THERE WAS NO CONTACT TO MUCOUS MEMBRANES OR BROKEN SKIN AND MEDICAL ATTENTION WAS NOT SOUGHT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL® DXH 800 COULTER® HMX CELLULAR ANALYSIS SYSTEM AUTOMATED DIFFERENTIAL CELL COUNTER GKZ BECKMAN COULTER INC. DXH 800 NA

    Patients

    Seq Age Sex Outcome Treatment
    1