BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER® LH500 HEMATOLOGY ANALYZER

    MDR report key: 2855178 · Received December 3, 2012

    Report

    Report Number
    1061932-2012-02780
    Event Type
    Malfunction
    Date Received
    December 3, 2012
    Date of Event
    November 9, 2012
    Report Date
    November 9, 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
    VA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER REPORTED THAT THE COULTER LH500 HEMATOLOGY ANALYZER LEAKED APPROXIMATELY ONE CUP OF FLUID. THE LEAK WAS OBSERVED DURING THE INSTRUMENT SHUTDOWN AND STARTUP PROCESS, AND WAS CONTAINED WITHIN THE INSTRUMENT. THE CUSTOMER WAS WEARING A LAB COAT, FACE-SHIELD, AND GLOVES AT THE TIME OF THE OCCURRENCE. THERE WAS NO REPORT OF INJURY OR EXPOSURE, 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) REPLACED THE TUBING WITH A HOLE AT PINCH VALVE, PV-43. THE LEAK WAS FIXED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1