BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER® LH750 HEMATOLOGY ANALYZER

    MDR report key: 2132097 · Received June 16, 2011

    Report

    Report Number
    1061932-2011-00694
    Event Type
    Malfunction
    Date Received
    June 16, 2011
    Date of Event
    May 17, 2011
    Report Date
    May 17, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    GKZ
    PMA / PMN Number
    K011342
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A FIELD SERVICE ENGINEER (FSE) WENT ON-SITE AND FOUND THE LYSE RESTRICTOR TUBING (LYSE AND DILUENT) TO HAVE LOST ITS ELASTICITY AND WAS SQUIRTING FLUID. FSE REPLACED THE TUBING AND THE ISSUE WAS RESOLVED.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) REPORTING THAT SHE WAS SPRAYED ON HER FACE AND ARM WHILE TROUBLESHOOTING A CONTROL ISSUE WITH BCI CTS (CUSTOMER TECHNICAL SUPPORT) ON THE COULTER LH750 HEMATOLOGY ANALYZER. THE OPERATOR WAS ADVISED TO USE PERSONAL PROTECTIVE EQUIPMENT (PPE) BEFORE TROUBLESHOOTING, HOWEVER THE OPERATOR OPTED NOT TO COMPLY. THE OPERATOR WAS SPRAYED WITH A SMALL AMOUNT OF LYSE WHEN SHE OPENED THE DOOR TO THE FRONT BATHS ABRUPTLY WHILE THE ANALYZER WAS STILL PERFORMING A RINSE CYCLE FUNCTION. THERE WAS NO DEATH OR INJURY ASSOCIATED WITH THIS EVENT AND NO ONE SOUGHT MEDICAL ATTENTION. THERE WAS NO REPORT OF EXPOSURE TO MUCOUS MEMBRANES OR OPEN WOUNDS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COULTER® LH750 HEMATOLOGY ANALYZER AUTOMATED DIFFERENTIAL CELL COUNTER GKZ BECKMAN COULTER INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1