BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER® LH 500 HEMATOLOGY ANALYZER

    MDR report key: 2983068 · Received February 28, 2013

    Report

    Report Number
    1061932-2013-00254
    Event Type
    Malfunction
    Date Received
    February 28, 2013
    Date of Event
    February 1, 2013
    Report Date
    February 1, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    PMA / PMN Number
    K032000
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A FIELD SERVICE ENGINEER (FSE) WENT ON-SITE AND OBSERVED THAT BELLOWS WAS NOT DRAINING. FSE REPLACED A MALFUNCTIONING PINCH VALVE (PV21) AND ACTUATOR WHICH RESOLVED THE ISSUE. THE CAUSE OF THE LEAK IS ATTRIBUTED TO PINCH VALVE PV21. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER (BEC) TO REPORT A 1 ML BLOOD LEAK FROM A COULTER LH 500 HEMATOLOGY ANALYZER AND ONTO THE COUNTER, WHILE SAMPLES WERE BEING RUN. NO ERRONEOUS RESULTS WERE GENERATED. THE CUSTOMER WAS WEARING PERSONAL PROTECTIVE EQUIPMENT (PPE) CONSISTING OF A GOWN, GLOVES AND GOGGLES AT THE TIME OF THE EVENT. NO INJURY OR EXPOSURE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    86098 COULTER® LH 500 HEMATOLOGY ANALYZER AUTOMATED DIFFERENTIAL CELL COUNTER GKZ BECKMAN COULTER LH 500 NA

    Patients

    Seq Age Sex Outcome Treatment
    1