BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LH 750 SLIDEMAKER

    MDR report key: 2043973 · Received April 7, 2011

    Report

    Report Number
    1061932-2011-00228
    Event Type
    Malfunction
    Date Received
    April 7, 2011
    Date of Event
    March 8, 2011
    Report Date
    March 8, 2011
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    GKZ
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER WAS WEARING GOWN, GLOVES, AND GOGGLES. THE CUSTOMER DISCONTINUED USE OF THIS INSTRUMENT. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED ON (B)(4) 2011. THE FSE INDICATED THE FITTING ON LUER LOCK FOR RINSE BLOCK HAD BROKEN LOOSE. THE LEAK WAS CLEANED AND THE LUER FITTING WAS REPLACED. REPAIR WAS VERIFIED AND UNIT IS OPERATIONAL. ROOT CAUSE FOR THE LEAK WAS ASSOCIATED WITH A DAMAGED RINSE BLOCK LUER FITTING.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) AND STATED THE LH 750 SLIDEMAKER INSTRUMENT WAS LEAKING BLOOD (APPROXIMATELY 20ML) INTO THE RIGHT BOTTOM TRAY. NO INJURIES OCCURRED AND MEDICAL ATTENTION WAS NOT SOUGHT. THERE WAS NO REPORT OF EXPOSURE TO MUCOUS MEMBRANES OR OPEN WOUNDS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LH 750 SLIDEMAKER LH 750 SLIDEMAKER GKZ BECKMAN COULTER, INC. NA

    Patients

    Seq Age Sex Outcome Treatment
    1