BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXH 800 COULTER® CELLULAR ANALYSIS SYSTEM

    MDR report key: 2930711 · Received January 28, 2013

    Report

    Report Number
    1061932-2013-00098
    Event Type
    Malfunction
    Date Received
    January 28, 2013
    Date of Event
    January 7, 2013
    Report Date
    January 7, 2013
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    GKZ
    PMA / PMN Number
    K081930
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    FAILURE MODE WAS DETERMINED TO BE A BUILDUP OF RUBBER PIECES IN THE NEEDLE HOUSING CAUSING MISALIGNMENT OF THE ASPIRATION NEEDLE. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A LEAK CONSISTING OF BLOOD AROUND THE TOP OF THE TUBES INVOLVING A UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEM. THE VOLUME OF THE LEAK WAS NOT REPORTED BUT THE LEAK WAS CONTAINED WITHIN THE INSTRUMENT. THE CUSTOMER WAS WEARING PERSONAL PROTECTIVE EQUIPMENT CONSISTING OF A LAB COAT AND GLOVES AND THERE WAS NO REPORT OF EXPOSURE OR INJURY. PATIENT RESULTS WERE NOT AFFECTED AND THERE WAS NO CHANGE OR AFFECT TO PATIENT TREATMENT IN CONNECTION WITH THIS EVENT. BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) FOUND THE LEAK COMING FROM A BUILDUP OF RUBBER PIECES FROM THE SAMPLE TUBE WHICH FORMS A SURFACE IN THE NEEDLE HOUSING. THE FSE NOTED THAT THE BUILDUP PREVENTED THE NEEDLE FROM REACHING THE PROPER ALIGNMENT TO REMOVE ALL FLUIDS AFTER ASPIRATION. THE FSE INDICATED THAT THIS ISSUE CAUSED THE ASPIRATION PROBE TO LEAK FLUID ONTO THE TUBES AND SAMPLE ASPIRATION AREA DUE TO MISALIGNMENT. THE FSE REMOVED THE RUBBER PIECES FROM THE NEEDLE HOUSING AND REALIGNED THE ASPIRATION NEEDLE TO RESOLVE THE ISSUE. REPAIR WAS VERIFIED AND RESULTS MET PUBLISHED SPECIFICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    37171 UNICEL® DXH 800 COULTER® CELLULAR ANALYSIS SYSTEM COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER, INC. NA

    Patients

    Seq Age Sex Outcome Treatment
    1