BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER LH 780 HEMATOLOGY ANALYZER

    MDR report key: 4844934 · Received June 15, 2015

    Report

    Report Number
    1061932-2015-00996
    Event Type
    Malfunction
    Date Received
    June 15, 2015
    Date of Event
    May 26, 2015
    Report Date
    May 26, 2015
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    PMA / PMN Number
    K061616
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A FIELD SERVICE ENGINEER (FSE) EVALUATED THE INSTRUMENT ON 05/27/2015. THE FSE FOUND A LEAK AT THE TUBING THROUGH PINCH VALVE VL46A. THE FSE REPLACED THE TUBING, WHICH REPAIRED THE LEAK. THE REPAIRS WERE VERIFIED PER ESTABLISHED PROCEDURES. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A LEAK FROM THE COULTER LH 780 HEMATOLOGY ANALYZER. THE VOLUME OF THE LEAK WAS ABOUT 30 ML AND WAS NOT CONTAINED WITHIN THE INSTRUMENT. THE CUSTOMER WAS WEARING PERSONAL PROTECTIVE EQUIPMENT (PPE) CONSISTING OF GLOVES, EYE PROTECTION AND A LABORATORY COAT AT THE TIME OF THE OCCURRENCE AND THERE WAS NO REPORT OF INJURY OR DIRECT EXPOSURE TO THE LEAK. ERRONEOUS PATIENT RESULTS WERE NOT 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
    389686 COULTER LH 780 HEMATOLOGY ANALYZER COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1