BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER® LH 500 HEMATOLOGY ANALYZER

    MDR report key: 2147988 · Received July 2, 2011

    Report

    Report Number
    1061932-2011-00784
    Event Type
    Malfunction
    Date Received
    July 2, 2011
    Date of Event
    June 1, 2011
    Report Date
    June 1, 2011
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    GKZ
    PMA / PMN Number
    K042724
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BEC FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED FOR THIS EVENT. THE FSE FOUND A PINHOLE IN THE TUBING THAT GOES THROUGH A PINCH VALVE IN THE MAIN DILUTER MODULE. THE TUBING WAS REPLACED AND THE AFFECTED AREA WAS CLEANED PER LABORATORY PROTOCOL. REPAIRS PER ESTABLISHED PROCEDURES WERE VERIFIED. ROOT CAUSE FOR THE LEAK IS ASSOCIATED WITH THE PINHOLE IN THE TUBING. AS 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 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 REPORTED TO BECKMAN COULTER, INC. (BEC) A FLUID CLENZ LEAK THAT WAS SEEN DRIPPING DURING STARTUP UNDER THE COULTER LH 500 HEMATOLOGY ANALYZER. AFTER THE INCIDENT, THE UNIT WAS POWERED OFF. THE OPERATOR WAS WEARING PERSONAL PROTECTIVE EQUIPMENT (PPE) CONSISTING OF LAB COAT AND GLOVES AT THE TIME OF THE INCIDENT. NO INJURIES OCCURRED AND MEDICAL ATTENTION WAS NOT SOUGHT. THERE WAS NO REPORT OF EXPOSURE TO MUCOUS MEMBRANES OR OPEN WOUNDS. THERE WAS NO DEATH, INJURY OR CHANGE TO PATIENT TREATMENT AS A RESULT OF THIS INCIDENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1