BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXH 800 COULTER® CELLULAR ANALYSIS SYSTEM

    MDR report key: 2849824 · Received November 28, 2012

    Report

    Report Number
    1061932-2012-02786
    Event Type
    Malfunction
    Date Received
    November 28, 2012
    Date of Event
    October 31, 2012
    Report Date
    October 31, 2012
    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
    LA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A BEC FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED FOR THIS EVENT. THE FSE DID NOT SEE ANY ACTIVE LEAK ON THE DXH800 INSTRUMENT MIXING CHAMBERS AND COULD NOT DETERMINE WHETHER THE LEAK WAS FROM THE DIFFERENTIAL MIXING CHAMBER OR THE NUCLEATED RED BLOOD CELL (NRBC) MIXING CHAMBER. THE FSE WAS UNABLE TO DETERMINE THE CAUSE OF THE OVERFLOW BUT CLEARED ALL THE DRAIN PORTS IN THE DIFFERENTIAL, NRBC AND RETICULOCYTE CHAMBERS TO ASSURE THEY WERE ALL CLEAR OF DEBRIS. THE FSE VERIFIED ALL MIXING CHAMBERS WERE DRAINING PROPERLY TO RESOLVE THE ISSUE. FAILURE MODE - UNKNOWN, BUT SERVICE CLEANED ALL MIXING PORTS TO RESOLVE THE ISSUE. PER LABELING, BECKMAN COULTER, INC. URGES ITS CUSTOMERS TO COMPLY WITH ALL NATIONAL HEALTH AND SAFETY STANDARDS SUCH AS THE USE OF BARRIER PROTECTION. THIS MAY INCLUDE, BUT IT IS NOT LIMITED TO, PROTECTIVE EYEWEAR, GLOVES, AND SUITABLE LABORATORY ATTIRE WHEN OPERATING OR MAINTAINING THIS OR ANY OTHER AUTOMATED LABORATORY ANALYZER. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BEC) REPORTING A BROWN COLORED LEAK AROUND THE FRONT OF THE UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEM. THE VOLUME WAS UNKNOWN AND THE LEAK WAS CONTAINED INSIDE THE INSTRUMENT. THE CUSTOMER WAS WEARING PERSONAL PROTECTIVE EQUIPMENT (PPE) CONSISTING OF A LAB COAT AND GLOVES. THERE WAS NO CONTACT TO OPEN OR BROKEN SKIN OR MUCOUS MEMBRANES. NO ONE SOUGHT MEDICAL ATTENTION. NO ERRONEOUS RESULTS WERE GENERATED AS A RESULT OF THE LEAK.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1