BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER LH 500 HEMATOLOGY ANALYZER

    MDR report key: 2931018 · Received January 28, 2013

    Report

    Report Number
    1061932-2013-00103
    Event Type
    Malfunction
    Date Received
    January 28, 2013
    Date of Event
    January 5, 2013
    Report Date
    January 5, 2013
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    GKZ
    PMA / PMN Number
    K032000
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    CUSTOMER REPORTED TO BECKMAN COULTER, INC. (BEC) THAT THERE WAS A FLUID LEAK BY THE BLOOD SAMPLING VALVE OF THE COULTER LH 500 HEMATOLOGY ANALYZER. CUSTOMER REPORTED THE FLUID WAS NOT CONTAINED WITHIN THE INSTRUMENT. CUSTOMER REPORTED THAT ABOUT 2 ML OF FLUID MIGRATED ONTO THE COUNTER TOP. CUSTOMER REPORTED THE VOLUME OF THE LEAK WAS 2 ML. CUSTOMER REPORTED PATIENT RESULTS WERE NOT AFFECTED. THERE WAS NO REPORT OF ANY ADVERSE EVENT OR INJURY REQUIRING MEDICAL INTERVENTION OR PATIENT TREATMENT. A BEC FIELD SERVICE ENGINEER (FSE) TROUBLESHOT THE LEAK WITH THE CUSTOMER VIA THE TELEPHONE. THE CUSTOMER REPORTED TO THE FSE THAT THE TUBING HAD DISCONNECTED FROM THE BLOOD SAMPLING VALVE. CUSTOMER INDICATED THEY REATTACHED THE TUBING AND CLEANED THE BLOOD SAMPLING VALVE. CUSTOMER INDICATED THE START-UP FAILED AFTER THEY REATTACHED THE TUBING. THE FSE INSTRUCTED THE CUSTOMER TO PERFORM A SHUTDOWN. THE INSTRUMENT WAS LEFT IN SHUTDOWN FOR 45 MINUTES. CUSTOMER INDICATED STARTUP PASSED AND QUALITY CONTROLS WERE WITHIN EXPECTED RANGES AFTER THE CLEANING AND THE SHUTDOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    37741 COULTER LH 500 HEMATOLOGY ANALYZER COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1