BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER HMX HEMATOLOGY ANALYZER WITH AUTOLOADER

    MDR report key: 2304065 · Received October 21, 2011

    Report

    Report Number
    1061932-2011-01904
    Event Type
    Malfunction
    Date Received
    October 21, 2011
    Date of Event
    September 21, 2011
    Report Date
    September 21, 2011
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    GKZ
    PMA / PMN Number
    K010765
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE BECKMAN COULTER, INC. IDENTIFIER FOR THIS REPORT IS (B)(4).

    Description of Event or Problem · 1

    CUSTOMER CALLED TO REPORT A PROBE WASH BLOCK LEAK ON THE COULTER HMX HEMATOLOGY ANALYZER'S AUTOLOADER. CUSTOMER OBSERVED A DILUENT DRIP AS THE SECONDARY BACKWASH WAS BEING PERFORMED. ON THE SAME DAY, THE FIELD SERVICE ENGINEER (FSE) INSPECTED THE INSTRUMENT AND FOUND THAT THE PROBE WASH BLOCK WAS NOT FUNCTIONING PROPERLY BECAUSE A LINEAR BEARING WAS OBSTRUCTED WITH UNIDENTIFIED RESIDUE. THIS CAUSED THE RINSE BLOCK TO OVERFLOW AND SPILL. THE FSE THEN CLEANED THE BEARING AND VERIFIED THAT THE SERVICES PERFORMED EFFECTIVELY RESOLVED THE WASH BLOCK LEAK ISSUE. CUSTOMER STATED THAT NO ONE CAME IN CONTACT WITH THE FLUID AND THERE WAS NO IMPACT TO SAMPLE RESULTS AS A RESULT OF THIS ISSUE. ALSO, NO INJURY WAS REPORTED, NOR WAS MEDICAL ATTENTION SOUGHT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COULTER HMX HEMATOLOGY ANALYZER WITH AUTOLOADER COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER, INC. HMX AUTOLOADER

    Patients

    Seq Age Sex Outcome Treatment
    1