BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER LH 750 HEMATOLOGY ANALYZER

    MDR report key: 3822295 · Received May 20, 2014

    Report

    Report Number
    1061932-2014-01153
    Event Type
    Malfunction
    Date Received
    May 20, 2014
    Date of Event
    April 28, 2014
    Report Date
    April 28, 2014
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    PMA / PMN Number
    K011342
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED. THE FSE FOUND CUT TUBING AT PORT 2 AT THE DIFF MIXING MODULE (VC25). THE FSE REPLACED THE CUT TUBING TO RESOLVE THE LEAK REPORTED. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A FLUID LEAK INSIDE THE LH750 INSTRUMENT. THE VOLUME OF THE LEAK WAS NOT REPORTED AND THE LEAK WAS CONTAINED. THERE WAS NO BIOHAZARD EXPOSURE TO MUCOUS MEMBRANES OR OPEN WOUNDS. IN ADDITION, NO ERRONEOUS RESULTS WERE GENERATED IN CONNECTION WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    300803 COULTER LH 750 HEMATOLOGY ANALYZER COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1