BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER® HMX HEMATOLOGY ANALYZER WITH AUTOLOADER

    MDR report key: 2798229 · Received October 22, 2012

    Report

    Report Number
    1061932-2012-02567
    Event Type
    Malfunction
    Date Received
    October 22, 2012
    Date of Event
    September 26, 2012
    Report Date
    September 26, 2012
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    GKZ
    PMA / PMN Number
    K010765
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A PROBE LEAKED A SMALL ABOUT OF BLOOD ON THE COULTER HMX HEMATOLOGY ANALYZER WITH AUTOLOADER. THE LEAK WAS NOT CONTAINED WITHIN THE INSTRUMENT. THE FLUIDS ASSOCIATED WITH THE LEAK ARE BLOOD, DILUENT AND CLENZ. THE CUSTOMER WAS WEARING PERSONAL PROTECTIVE EQUIPMENT CONSISTING OF GLOVES, EYE PROTECTION, AND LABORATORY COAT WHEN THE LEAK WAS FOUND. THE CUSTOMER DID NOT COME IN CONTACT WITH THE FLUID AND DID NOT SEEK MEDICAL ATTENTION. NO EXPOSURE (SPRAYED OR SPLASHED) TO MUCOUS MEMBRANES OR OPEN WOUNDS WERE REPORTED. NO DEATH, INJURY OR CHANGES TO PATIENT TREATMENT OR RESULTS ARE ASSOCIATED WITH THIS EVENT. THE CUSTOMER DID NOT REVIEW THE MSDS; HOWEVER, THE FACILITY DOES HAVE A RISK MANAGEMENT / EXPOSURE CONTROL PLAN IS IN PLACE. ON THE DAY OF THE EVENT, A FIELD SERVICE ENGINEER (FSE) WAS ON SITE AND FOUND THE PROBE WASH CYLINDER SLUGGISH. THE FSE LUBRICATED THE SLIDE AND THE BEARINGS THAT ALLOWED THE RINSE BLOCK TO MOVE PROPERLY TO NORMAL POSITION; HENCE RESOLVING THE ISSUE. THE FAILURE MODE WAS THE PROBE WASH CYLINDER.

    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. N/A

    Patients

    Seq Age Sex Outcome Treatment
    1