BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER® LH 780 HEMATOLOGY ANALYZER

    MDR report key: 3011806 · Received March 19, 2013

    Report

    Report Number
    1061932-2013-00450
    Event Type
    Malfunction
    Date Received
    March 19, 2013
    Date of Event
    February 20, 2013
    Report Date
    February 20, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    PMA / PMN Number
    K061616
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A FIELD SERVICE ENGINEER (FSE) WENT ON-SITE AND CONFIRMED DRIED BLOOD UNDERNEATH THE BLOOD DETECTORS ON THE INSTRUMENT AND FOUND A PINHOLE SIZE LEAK IN THE VENT LINE FROM THE NEEDLE. FSE REPLACED THE VENT LINE TUBING FROM THE NEEDLE WHICH RESOLVED THE LEAK. THE CAUSE OF THE LEAK IS ATTRIBUTED TO A PINHOLE SIZE LEAK IN THE NEEDLE VENT LINE TUBING. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER (BEC) TO REPORT PARTIALLY DRIED BLOOD AND A WET BLOOD AND DILUENT MIXTURE NEAR THE BLOOD DETECTOR AREA OF A COULTER LH 780 HEMATOLOGY ANALYZER. THE VOLUME OF THE LEAK WAS REPORTED AS 5 ML AND THE LEAK WAS CONTAINED INSIDE THE INSTRUMENT. THE CUSTOMER WAS WEARING PERSONAL PROTECTIVE EQUIPMENT (PPE) CONSISTING OF GLOVES AND A LAB COAT AT THE TIME OF THE EVENT. NO INJURY OR EXPOSURE WAS REPORTED AND THERE WAS NO AFFECT TO PATIENT SAMPLES OR RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    114299 COULTER® LH 780 HEMATOLOGY ANALYZER AUTOMATED DIFFERENTIAL CELL COUNTER GKZ BECKMAN COULTER LH 780 NA

    Patients

    Seq Age Sex Outcome Treatment
    1