BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER® LH 750 HEMATOLOGY ANALYZER

    MDR report key: 3171366 · Received June 14, 2013

    Report

    Report Number
    1061932-2013-01055
    Event Type
    Malfunction
    Date Received
    June 14, 2013
    Date of Event
    May 17, 2013
    Report Date
    May 17, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    PMA / PMN Number
    K011342
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A BECKMAN COULTER FSE (FIELD SERVICE ENGINEER) WAS DISPATCHED AND DISCOVERED A CUT IN VENT LINE FOR THE SAMPLE PROBE. THE FSE TRIMMED THE CUT TUBING, RE-INSERTED THE TUBING ONTO THE VENT PORT OF THE PIERCING NEEDLE AND VERIFIED VLS (VENT LINE SENSOR) FUNCTION BY RUNNING DIAGNOSTICS WHICH PASSED. THE FSE CLEANED THE INTERIOR OF THE INSTRUMENT AND THE BENCH FROM DILUENT CRYSTALLIZATION AND VERIFIED REPAIR PER ESTABLISHED PROCEDURES. FAILURE MODE IS ATTRIBUTED TO A CUT TUBING ON THE VENT PORT OF THE PIERCING NEEDLE. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A YELLOWISH FLUID LEAK OF ABOUT 1 FOOT LONG IN THE BACK OF THE COULTER LH 750 HEMATOLOGY ANALYZER WHICH WAS NOT CONTAINED WITHIN THE INSTRUMENT. THE CUSTOMER WAS WEARING PERSONAL PROTECTIVE EQUIPMENT CONSISTING OF GLOVES, A LABORATORY COAT, AND EYEGLASSES 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
    271934 COULTER® LH 750 HEMATOLOGY ANALYZER COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1