BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXH 800 COULTER® CELLULAR ANALYSIS SYSTEM

    MDR report key: 2060470 · Received April 17, 2011

    Report

    Report Number
    1061932-2011-00266
    Event Type
    Malfunction
    Date Received
    April 17, 2011
    Date of Event
    March 18, 2011
    Report Date
    March 18, 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
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FSE ADJUSTED THE SLACK ON THE PROBE WASH COLLAR TUBING. PER LABELING, BECKMAN COULTER URGES ITS CUSTOMERS TO COMPLY WITH ALL NATIONAL HEALTH AND SAFETY STANDARDS SUCH AS THE USE OF BARRIER PROTECTION. THIS MAY INCLUDE, BUT IS NOT LIMITED TO, WEARING PROTECTIVE EYE WEAR, GLOVES, AND SUITABLE LABORATORY ATTIRE WHEN OPERATING OR MAINTAINING THIS INSTRUMENT OR ANY OTHER AUTOMATED LABORATORY ANALYZER. ROOT CAUSE IS ASSOCIATED WITH THE MOVEMENT OF SINGLE TUBE PRESENTATION (MANUAL) STATION CAUSING THE TUBING COIL TO CATCH AND BE STRETCH WHICH IN TURN CAUSED THE WASH COLLAR TO BE RAISED UP. THIS WOULD NOT ALLOW THE WASH COLLAR TO RETURN TO THE CORRECT POSITION, CAUSING BLOOD SPLATTER.

    Description of Event or Problem · 1

    BECKMAN COULTER INC. (BCI) FIELD SERVICE ENGINEER (FSE) FOUND DRIED BLOOD SPLATTER ON TOP OF NRBC AND DIFF CHAMBER WHILE TROUBLESHOOTING THE CUSTOMER'S UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEM. CUSTOMER WAS NOT AWARE OF THE DRIED BLOOD BECAUSE ALL COVERS WERE ON THE ANALYZER. FSE WAS WEARING LATEX GLOVES AND CLEANED THE DRIED BLOOD. THERE WAS NO CONTACT TO MUCOUS MEMBRANE OR OPEN WOUNDS. NO ONE SOUGHT MEDICAL ATTENTION.

    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 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1