BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER® LH 500 HEMATOLOGY INSTRUMENT

    MDR report key: 2990761 · Received March 5, 2013

    Report

    Report Number
    1061932-2013-00353
    Event Type
    Malfunction
    Date Received
    March 5, 2013
    Date of Event
    February 4, 2013
    Report Date
    February 4, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    PMA / PMN Number
    K032000
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER HAD REPLACED A TORN YELLOW STRIPE PINCH TUBING AT NORMALLY CLOSED PV66 THAT FIXED THE LEAK, AND DETERMINED THAT NO ADDITIONAL HELP WAS NEEDED AT THIS TIME FROM A BEC FIELD SERVICE ENGINEER (FSE). PER THE OPERATOR'S GUIDE / IFU: WARNINGS AND PRECAUTIONS: BECKMAN COULTER 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. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER (BEC) REPORTING A LEAK OF CLEAR FLUID DRIPPING FROM UNDER THE COULTER LH 500 HEMATOLOGY INSTRUMENT WHILE RUNNING CONTROLS. THE VOLUME OF FLUID WAS APPROXIMATELY 5 MLS. THE OPERATOR WAS WEARING PERSONAL PROTECTIVE EQUIPMENT (PPE) CONSISTING OF A LABORATORY COAT AND GLOVES DURING THE EVENT. THERE WAS NO BIOHAZARD EXPOSURE TO OPEN WOUNDS OR MUCOUS MEMBRANES. NO ONE SOUGHT MEDICAL ATTENTION. NO ERRONEOUS RESULTS WERE GENERATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    93025 COULTER® LH 500 HEMATOLOGY INSTRUMENT COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER LH 500 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1