BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER LH 750 HEMATOLOGY ANALYZER

    MDR report key: 4123399 · Received September 26, 2014

    Report

    Report Number
    1061932-2014-02457
    Event Type
    Malfunction
    Date Received
    September 26, 2014
    Date of Event
    August 31, 2014
    Report Date
    August 31, 2014
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    PMA / PMN Number
    K061574
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER WAS ABLE TO RESOLVE THE LEAK. BECKMAN COULTER (BEC) FIELD SERVICE WAS NOT DISPATCHED FOR THIS EVENT. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A LEAK FROM A COULTER LH 750 HEMATOLOGY ANALYZER. THE INSTRUMENT ALSO GENERATED LOW VACUUM ERRORS AT THE TIME OF THE LEAK. THE VOLUME OF THE LEAK WAS APPROXIMATELY 50 ML AND WAS NOT CONTAINED WITHIN THE INSTRUMENT. THE INSTRUMENT OPERATOR WAS WEARING GLOVES, GLASSES, AND A LAB COAT AT THE TIME OF THE LEAK. THERE WERE NO REPORTS OF BIOHAZARD EXPOSURE TO THE LEAK. THERE WERE NO ERRONEOUS RESULTS GENERATED AND PATIENT TREATMENT WAS NOT IMPACTED IN CONNECTION WITH THIS EVENT. THE CUSTOMER TROUBLESHOOTED THE LEAK AND FOUND THE SAMPLE LINE WAS DISCONNECTED FROM THE BLOOD SAMPLING VALVE (BSV). THE CUSTOMER REATTACHED THE TUBING; THE LEAK AND ERRORS WERE RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    600424 COULTER LH 750 HEMATOLOGY ANALYZER COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1