BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER® LH500 HEMATOLOGY ANALYZER

    MDR report key: 2925949 · Received January 23, 2013

    Report

    Report Number
    1061932-2013-00043
    Event Type
    Malfunction
    Date Received
    January 23, 2013
    Date of Event
    December 27, 2012
    Report Date
    December 27, 2012
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    GKZ
    PMA / PMN Number
    K032000
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    BECKMAN COULTER FIELD SERVICE ENGINEER ASSISTED THE CUSTOMER OVER THE PHONE WITH TROUBLESHOOTING AND RESOLVED THE ISSUE. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER REPORTED THAT THE COULTER LH500 HEMATOLOGY ANALYZER LEAKED APPROXIMATELY 20 TO 40ML OF LH DILUENT. A TUBING WAS DISCONNECTED AT A PINCH VALVE (PV15) WHILE THE INSTRUMENT WAS PRIMING THE LH DILUENT, AND SPEWED FLUID ONTO THE TABLE, FLOOR, AND THE OPERATOR'S HAIR. THE OPERATOR WAS WEARING A LAB COAT, GLOVES, AND EYE GLASSES AT THE TIME OF THE OCCURRENCE. THE OPERATOR FLUSHED HER HAIR WITH WATER. THERE WAS NO REPORT OF INJURY OR EXPOSURE TO OPEN WOUNDS OR MUCOUS MEMBRANE, AND MEDICAL ATTENTION WAS NOT SOUGHT. MATERIAL SAFETY DATA SHEET (MSDS) WAS REVIEWED, AND THERE IS AN EXPOSURE CONTROL PLAN IN PLACE AT THE FACILITY. NO ERRONEOUS PATIENT RESULTS WERE GENERATED IN CONNECTION WITH THIS LEAK. BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) ASSISTED THE CUSTOMER OVER THE PHONE WITH REPLACING TUBING THROUGH THE PINCH VALVE 15, AND THE ISSUE WAS RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    31824 COULTER® LH500 HEMATOLOGY ANALYZER DIFFERENTIAL CELL COUNTER GKZ BECKMAN COULTER, INC. LH500 NA

    Patients

    Seq Age Sex Outcome Treatment
    1