BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER® LH 750

    MDR report key: 2132522 · Received June 17, 2011

    Report

    Report Number
    1061932-2011-00665
    Event Type
    Malfunction
    Date Received
    June 17, 2011
    Date of Event
    May 19, 2011
    Report Date
    May 19, 2011
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    GKZ
    PMA / PMN Number
    K011342
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A FIELD SERVICE ENGINEER (FSE) FOUND BACKWASH LINE TO BLOOD SAMPLE VALVE (BSV) LEAKING. THE FSE REPLACED THE LINE AND VL64 AND VALIDATED THE INSTRUMENT. THE ROOT CAUSE IS A LEAKING BACKWASH LINE TO THE BSV.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC., (BCI) AND REPORTED THAT THE COULTER LH 750 ANALYZER HAD BEEN RUNNING WITH NO ERRORS WHEN THE OPERATOR NOTICED SOME DRIPS OF DILUENT AT REAR OF THE INSTRUMENT BEHIND LEFT PANEL. CUSTOMER STOPPED USING THE INSTRUMENT AND REQUESTED SERVICE. THE CUSTOMER WAS WEARING GLOVES AND A LAB COAT. THERE WAS NO EXPOSURE TO MUCOUS MEMBRANES OR OPEN WOUNDS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COULTER® LH 750 HEMATOLOGY ANALYZER GKZ BECKMAN COULTER, INC. LH 750 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1