BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER LH 750 HEMATOLOGY ANALYZER

    MDR report key: 4143321 · Received October 6, 2014

    Report

    Report Number
    1061932-2014-02521
    Event Type
    Malfunction
    Date Received
    October 6, 2014
    Date of Event
    September 7, 2014
    Report Date
    September 7, 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 HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE FSE DETERMINED THE PRIMARY ASPIRATION TUBING TO THE BLOOD SAMPLING VALVE (BSV) WAS LOOSE CAUSING A FEW DROPS OF BLOOD TO LEAK. THE FSE TRIMMED THE TUBING AND RE-ATTACHED IT TO THE BSV RESOLVING THE LEAK AND ERRATIC QC RESULTS. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A COULTER LH 750 HEMATOLOGY ANALYZER GENERATED ERRATIC AND OUT-OF-SPECIFICATION QUALITY CONTROL (QC) RESULTS. A BECKMAN COULTER (BEC) FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO EVALUATE THE INSTRUMENT. THE FSE FOUND A FEW DROPS OF BLOOD LEAKING FROM THE ASPIRATION TUBING TO THE BLOOD SAMPLING VALVE (BSV). THE LEAK WAS CONTAINED WITHIN THE INSTRUMENT. THE FSE WAS WEARING GLOVES, A LAB COAT, AND EYEWEAR WHEN THE LEAK WAS FOUND. THERE WERE NO REPORTS OF BIOHAZARD EXPOSURE TO THE LEAK. THERE WAS NO IMPACT TO PATIENT RESULTS OR PATIENT TREATMENT IN CONNECTION WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    623044 COULTER LH 750 HEMATOLOGY ANALYZER COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1