BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER® LH 500 HEMATOLOGY ANALYZER

    MDR report key: 2884478 · Received December 22, 2012

    Report

    Report Number
    1061932-2012-02834
    Event Type
    Malfunction
    Date Received
    December 22, 2012
    Date of Event
    November 27, 2012
    Report Date
    November 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
    OH, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A FIELD SERVICE ENGINEER (FSE) WENT ON-SITE AND REPLACED TUBING THROUGH PINCH VALVE PV43 (DRAIN PATH FROM WASTE CHAMBER VC1) THAT WAS FOUND TO BE LEAKING WHICH RESOLVED THE ISSUE. THE CAUSE OF THE LEAK IS ASSOCIATED WITH THE TUBING AT PV43. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BEC) STATING THAT THEIR COULTER LH 500 HEMATOLOGY ANALYZER LEAKED LH CLEANER. THE LEAK WAS NOT CONTAINED WITHIN THE UNIT, SOME FLUID WENT ONTO THE COUNTER. THE VOLUME OF THE LEAK WAS UNKNOWN. THE CUSTOMER WAS WEARING PERSONAL PROTECTIVE EQUIPMENT (PPE) CONSISTING OF A LAB COAT, GLASSES AND GLOVES AT THE TIME OF THE INCIDENT. NO INJURY OR EXPOSURE WAS REPORTED AND THERE WAS NO AFFECT TO PATIENT SAMPLES OR RESULTS.

    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