BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER® LH 780

    MDR report key: 2083167 · Received May 10, 2011

    Report

    Report Number
    1061932-2011-00399
    Event Type
    Malfunction
    Date Received
    May 10, 2011
    Date of Event
    April 12, 2011
    Report Date
    April 12, 2011
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    GKZ
    PMA / PMN Number
    K061616
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED AND REPLACED THE TUBING FROM T FITTING TO FLOW CELL. HARDWARE IS THE ROOT CAUSE FOR THIS EVENT.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC, (BCI) AND REPORTED THAT THEY OBTAINED A DIFF/VOLT ERROR MESSAGE ON THE COULTER LH 780 INSTRUMENT AND LATER DISCOVERED A FLUID LEAK OF BLOOD AND DILUENT. THE CUSTOMER STOPPED USING THE INSTRUMENT WHEN THE ERROR MESSAGE WAS GENERATED AN NO PATIENT RESULTS WERE AFFECTED. THE CUSTOMER WAS WEARING THE APPROPRIATE PERSONAL PROTECTIVE EQUIPMENT (PPE). NO INJURIES OCCURRED IN CONNECTION WITH THIS EVENT. THERE WAS NO EXPOSURE, OR CONTACT WITH EYES OR SKIN, OPEN WOUNDS OR MUCOUS MEMBRANE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COULTER® LH 780 HEMATOLOGY ANALYZER GKZ BECKMAN COULTER, INC. LH 780 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1