BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER® LH 500 HEMATOLOGY ANALYZER

    MDR report key: 2091488 · Received May 17, 2011

    Report

    Report Number
    1061932-2011-00417
    Event Type
    Malfunction
    Date Received
    May 17, 2011
    Date of Event
    April 17, 2011
    Report Date
    April 17, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    GKZ
    PMA / PMN Number
    K032000
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BCI FIELD SERVICE ENGINEER (FSE) REPLACED PINCH VALVE 21 AND ITS TUBING (BLOOD, DILUENT AND CLENZ) ROOT CAUSE IS ATTRIBUTED TO FAULTY PINCH VALVE 21 TUBING. PER LABELING, BECKMAN COULTER INC. URGES ITS CUSTOMERS TO COMPLY WITH ALL NATIONAL HEALTH AND SAFETY STANDARDS SUCH AS THE USE OF BARRIER PROTECTION. THIS MAY INCLUDE, BUT IT IS NOT LIMITED TO, PROTECTIVE EYEWEAR, GLOVES, AND SUITABLE LABORATORY ATTIRE WHEN OPERATING OR MAINTAINING THIS OR ANY OTHER AUTOMATED LABORATORY ANALYZER.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC (BCI) TO REPORT CLEANER LEAKING OUT OF THE COULTER LH 500 HEMATOLOGY ANALYZER DURING SHUTDOWN. AFTER PERFORMING STARTUP AND RUNNING CONTROLS, THE CUSTOMER NOTICED BLOOD LEAKING FROM THE INSTRUMENT ONTO THE COUNTER AND DRIPPING ON THE FLOOR. USER WAS WEARING PERSONAL PROTECTIVE EQUIPMENT (PPE). THERE WAS NO EXPOSURE OR CONTACT WITH THE EYES, OR SKIN, MUCOUS MEMBRANES OR OPEN WOUNDS. THE OPERATOR DID NOT SEEK MEDICAL ATTENTION. THERE WAS NO EFFECT TO PATIENTS OR END USER.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1