BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LH 500 HEMATOLOGY ANALYZER

    MDR report key: 3251191 · Received July 29, 2013

    Report

    Report Number
    1061932-2013-01562
    Event Type
    Malfunction
    Date Received
    July 29, 2013
    Date of Event
    July 9, 2013
    Report Date
    July 9, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    PMA / PMN Number
    K032000
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER'S SITE. THE FSE CONFIRMED THE LEAK FROM THE NEEDLE AND THE COUPLING. THE FSE REPLACED THE NEEDLE ASSEMBLY AND THE COUPLING TO RESOLVE THE LEAK. REPAIR WAS VERIFIED PER ESTABLISHED PROCEDURES AND RESULTS MET PUBLISHED SPECIFICATIONS. FAILURE MODE OF THE LEAK IS ATTRIBUTED TO THE NEEDLE ASSEMBLY AND COUPLING WHICH NEEDED TO BE REPLACED. RESULTS: NEEDLE ASSEMBLY AND COUPLING. BECKMAN COULTER INTERNAL IDENTIFIER FOR THIS REPORT IS (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT APPROXIMATELY LESS THAN 5 ML OF FLUID LEAKED FROM THE NEEDLE AT LUER LOCK #1 FITTING OF THE LH 500 HEMATOLOGY ANALYZER . THE CUSTOMER ATTEMPTED TO TIGHTEN THE FITTING BUT THE LEAK WAS NOT RESOLVED. THE CUSTOMER INDICATED THAT THE LEAK WAS NOT CONTAINED WITHIN THE INSTRUMENT. THE CUSTOMER WAS WEARING PERSONAL PROTECTIVE EQUIPMENT CONSISTING OF GLOVES AND A LABORATORY COAT AT THE TIME OF THE EVENT AND NO INJURY OR EXPOSURE WAS REPORTED. NO ERRONEOUS PATIENT RESULTS WERE GENERATED AND THERE WAS NO CHANGE OR AFFECT TO PATIENT TREATMENT IN CONNECTION WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    352844 LH 500 HEMATOLOGY ANALYZER COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1