BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER LH 750 HEMATOLOGY ANALYZER

    MDR report key: 2589553 · Received May 27, 2012

    Report

    Report Number
    1061932-2012-01765
    Event Type
    Malfunction
    Date Received
    May 27, 2012
    Date of Event
    May 2, 2012
    Report Date
    May 2, 2012
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    GKZ
    PMA / PMN Number
    K011342
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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 CLEAR LIQUID LEAK AROUND THE PIERCING NEEDLE ASSEMBLY OF THE COULTER LH 750 HEMATOLOGY ANALYZER (LH 750). CUSTOMER REPORTED THAT THE LH 750 WAS GIVING "VLS DILUENT ERRORS" (VENT LINE SENSOR DILUENT ERRORS). CUSTOMER REPORTED THE VOLUME OF THE LEAK WAS LESS THAN 5 ML. CUSTOMER REPORTED THE LEAK WAS CONTAINED INSIDE THE INSTRUMENT. CUSTOMER REPORTED THAT PATIENT RESULTS WERE NOT AFFECTED. THERE WAS NO REPORT OF ANY ADVERSE EVENT OR INJURY REQUIRING MEDICAL INTERVENTION OR PATIENT TREATMENT. BEC FIELD SERVICE ENGINEER (FSE) TROUBLESHOT THE ISSUE WITH THE CUSTOMER VIA THE TELEPHONE. THE FSE AND THE CUSTOMER FOUND THE NEEDLE WAS LEAKING DUE TO A PLUG IN THE ASPIRATION PATHWAY. THE FSE GUIDED THE CUSTOMER IN CLEARING THE PLUG IN THE ASPIRATION PATHWAY WITH BLEACH SOLUTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COULTER LH 750 HEMATOLOGY ANALYZER COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1