BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER® LH 500 HEMATOLOGY ANALYZER

    MDR report key: 2821719 · Received November 6, 2012

    Report

    Report Number
    1061932-2012-02644
    Event Type
    Malfunction
    Date Received
    November 6, 2012
    Date of Event
    October 15, 2012
    Report Date
    October 15, 2012
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    GKZ
    PMA / PMN Number
    K032000
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE ON (B)(4) 2012. THE FSE REPLACED THE NEEDLE CARTRIDGE THAT HAD A FAULTY SEAL. THE FSE BACKWASHED VACUUM LINES AND REPLACED THE VACUUM CHOKE LINE UNDER THE PUMP MODULE TO ENSURE PROPER VACUUM FOR THE NEEDLE BACKWASH. THE FSE CONFIRMED PROPER ASPIRATION AND OBSERVED NO LEAKS. 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. CAUSE OF THIS EVENT WAS THE NEEDLE CARTRIDGE THAT HAD A FAULTY SEAL. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC., (BEC) AND REPORTED THAT ABOUT 2 TO 4ML OF CLEAR BLUE LIQUID LEAKED FROM THE COULTER LH 500 HEMATOLOGY ANALYZER. THE LEAK WAS NOT CONTAINED WITHIN THE INSTRUMENT. THE UNIT WAS IN SHUTDOWN MODE AND NO RESULTS HAD BEEN RUN. THE LABORATORY PERSONNEL WAS WEARING PERSONAL PROTECTIVE EQUIPMENT (PPE), CONSISTING OF GOWNS, GLOVES, AND GOGGLES. THERE WAS NO BIOHAZARD EXPOSURE TO MUCOUS MEMBRANES OR OPEN WOUNDS. NO DISCREPANT RESULTS WERE GENERATED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1