BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER® LH 500 HEMATOLOGY ANALYZER

    MDR report key: 3011831 · Received March 19, 2013

    Report

    Report Number
    1061932-2013-00452
    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
    K032000
    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 THE LEAK WAS FROM THE BLOOD SAMPLING VALVE. FSE REPLACED ALL THE TUBING CONNECTING TO PV49 WHICH RESOLVED THE LEAK. THE TUBING THAT GOES FROM FF174 TO FF180 (PV49 VALVE) IS USED TO COLLECT THE WASTE FROM THE PROBE WASH (EXTERNAL CLEANING OF THE MANUAL PROBE). AFTER A MANUAL ASPIRATION IS COMPLETED, THE MANUAL PROBE IS WASHED OUTSIDE AND INSIDE. REPAIR WAS VERIFIED PER ESTABLISHED PROCEDURES AND RESULTS MET PUBLISHED PERFORMANCE SPECIFICATIONS. THE CAUSE OF THE LEAK IS ATTRIBUTED TO THE TUBING AT PV49. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER (BEC) TO REPORT 6 - 8 DROPS OF FLUID LEAKED FROM THE PROBE OF A COULTER LH 500 HEMATOLOGY ANALYZER FOLLOWING THE PROBE RINSE CYCLE THAT TAKES PLACE AFTER THE INSTRUMENT PROCESSES A RETIC SAMPLE ONLY. THE CUSTOMER WAS WEARING PERSONAL PROTECTIVE EQUIPMENT (PPE) CONSISTING OF A LABCOAT AND GLOVES 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
    113859 COULTER® LH 500 HEMATOLOGY ANALYZER AUTOMATED DIFFERENTIAL CELL COUNTER GKZ BECKMAN COULTER LH 500 NA

    Patients

    Seq Age Sex Outcome Treatment
    1