BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER® LH 500 HEMATOLOGY ANALYZER

    MDR report key: 2990449 · Received March 5, 2013

    Report

    Report Number
    1061932-2013-00286
    Event Type
    Malfunction
    Date Received
    March 5, 2013
    Date of Event
    February 10, 2013
    Report Date
    February 10, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    PMA / PMN Number
    K032000
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER FOUND THE LEAK AT QUICK DISCONNECT TUBING THAT GOES TO PINCH VALVE PV22 (PV22 PROVIDES AN OPEN PATH FOR PRESSURIZED DILUENT FOR NEEDLE RINSE) AND RECONNECTED THE TUBING WHICH RESOLVED THE LEAK; HOWEVER, THE CONTROLS WERE RUNNING LOW. A FIELD SERVICE ENGINEER (FSE) WENT ON-SITE AND REPLACED THE TUBING AT PV22 AND RAN PERFORMANCE TESTS WHICH WERE WITHIN SPECIFICATIONS. THE CAUSE OF THE LEAK MAY BE ATTRIBUTED TO THE QUICK DISCONNECT TUBING THAT GOES TO PV22. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER (BEC) TO REPORT A LEAK OF BLOOD DRIPPING FROM UNDER A COULTER LH 500 HEMATOLOGY ANALYZER. THE VOLUME OF THE LEAK WAS APPROXIMATELY 10ML. THE CUSTOMER WAS WEARING PERSONAL PROTECTIVE EQUIPMENT (PPE) CONSISTING OF GLOVES AND A LABCOAT AT THE TIME OF THE EVENT. NO INJURY OR EXPOSURE WAS REPORTED. NO ERRONEOUS RESULTS WERE GENERATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    93786 COULTER® LH 500 HEMATOLOGY ANALYZER AUTOMATED DIFFERENTIAL CELL COUNTER GKZ BECKMAN COULTER LH 500 NA

    Patients

    Seq Age Sex Outcome Treatment
    1