BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER® LH 750 HEMATOLOGY ANALYZER

    MDR report key: 2151777 · Received July 6, 2011

    Report

    Report Number
    1061932-2011-00840
    Event Type
    Malfunction
    Date Received
    July 6, 2011
    Date of Event
    June 7, 2011
    Report Date
    June 7, 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
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A FIELD SERVICE ENGINEER (FSE) INDICATED THE LEAK WAS LOCATED AT VL5 AND SOL118. THE FSE REPLACED TUBES. RESULTS MEET PUBLISHED PERFORMANCE SPECIFICATIONS.. THE ROOT CAUSE WAS ATTRIBUTED TO LEAKING TUBES.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC., (BEC) AND REPORTED A FLUID LEAK ON LEFT SIDE OF THE COULTER LH 750 HEMATOLOGY ANALYZER THAT APPEARS TO BE DILUENT. THE CUSTOMER WAS WEARING PERSONAL PROTECTIVE EQUIPMENT (PPE) CONSISTING OF GLOVES AND A LAB COAT AT TIME OF THE EVENT. THERE WAS NO CONTACT WITH OPEN WOUNDS OR MUCOUS MEMBRANES. NO DEATH OR INJURY OCCURRED AND NO ONE REQUIRED MEDICAL ATTENTION.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1