BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER® LH 500 HEMATOLOGY ANALYZER

    MDR report key: 2567821 · Received May 9, 2012

    Report

    Report Number
    1061932-2012-01497
    Event Type
    Malfunction
    Date Received
    May 9, 2012
    Date of Event
    April 17, 2012
    Report Date
    April 17, 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
    TX, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    A FIELD SERVICE ENGINEER (FSE) WENT ON-SITE AND FOUND LEAKING BETWEEN THE PADS OF THE BSV (BLOOD SAMPLING VALVE) AND NOTED GRINDING ON THE EXTENSION/RETRACTION OF THE PROBE SECTION OF THE BSV. FSE REPLACED THE ACTUATOR WHICH HAD CAUSED THE BSV KNOB TO OVER-TIGHTEN AND PUT UNDUE PRESSURE ON THE PROBE SECTION OF THE BSV. FSE THEN RAN SEVERAL STARTUP AND SHUTDOWN CYCLES AND NO LEAKING WAS OBSERVED. STARTUP, LATRON AND CONTROLS ALL RECOVERED WITHIN SPECIFICATIONS. THE LEAK OCCURRED BECAUSE THE BSV ACTUATOR CAUSED THE BSV KNOB TO OVER-TIGHTEN. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC (BEC) STATING THAT ABOUT 5CC OF CLENZ (CLEANER) LEAKED ABOVE THE SECONDARY PROBE OF THEIR COULTER LH 500 HEMATOLOGY ANALYZER. THE LEAK WAS CONTAINED WITHIN THE INSTRUMENT. THERE IS AN EXPOSURE PLAN IN PLACE AT THE FACILITY. THE CUSTOMER WAS WEARING PERSONAL PROTECTIVE EQUIPMENT (PPE) CONSISTING OF GLOVES, GLASSES AND A LAB COAT AT THE TIME OF THE INCIDENT. NO INJURY OR EXPOSURE WAS REPORTED AND THERE WAS NO AFFECT TO PATIENT SAMPLES. PER CUSTOMER, THE LEAK APPEARS TO ONLY OCCUR DURING THE SHUTDOWN PROCESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COULTER® LH 500 HEMATOLOGY ANALYZER AUTOMATED DIFFERENTIAL CELL COUNTER GKZ BECKMAN COULTER INC. LH 500 NA

    Patients

    Seq Age Sex Outcome Treatment
    1