BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER LH 750 HEMATOLOGY ANALYZER

    MDR report key: 4153009 · Received October 8, 2014

    Report

    Report Number
    1061932-2014-02541
    Event Type
    Malfunction
    Date Received
    October 8, 2014
    Date of Event
    September 18, 2014
    Report Date
    September 18, 2014
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    PMA / PMN Number
    K061574
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A BECKMAN COULTER (BEC) FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO EVALUATE THE INSTRUMENT. THE FSE FOUND A FAULTY SEAL ON APERTURE 3 IN THE RED BLOOD CELL (RBC) BATH VC2. THE FSE REPLACED THE APERTURE SEAL WHICH RESOLVED THE LEAK AND ERRORS. REPAIRS WERE VERIFIED PER ESTABLISHED PROCEDURES. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A LEAK FROM AN UNKNOWN LOCATION INSIDE A COULTER LH 750 HEMATOLOGY ANALYZER. THE INSTRUMENT GENERATED VOLTAGE ERRORS WHEN THE LEAK WAS OBSERVED. THE VOLUME OF THE LEAK WAS ABOUT ONE CUP AND WAS NOT CONTAINED WITHIN THE INSTRUMENT. THE INSTRUMENT OPERATOR WAS WEARING GOGGLES, GLOVES, AND A LAB COAT AT THE TIME OF THE LEAK. THERE WERE NO REPORTS OF DIRECT CONTACT WITH THE LEAK. THERE WERE NO ERRONEOUS RESULTS GENERATED AND PATIENT TREATMENT WAS NOT IMPACTED IN CONNECTION WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    631990 COULTER LH 750 HEMATOLOGY ANALYZER COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1