BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 600I SYNCHRON® ACCESS® CLINICAL SYSTEM

    MDR report key: 2183438 · Received July 28, 2011

    Report

    Report Number
    2050012-2011-03320
    Event Type
    Malfunction
    Date Received
    July 28, 2011
    Date of Event
    June 28, 2011
    Report Date
    June 28, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJE
    PMA / PMN Number
    K060256
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BEC CTS (CUSTOMER TECHNICAL SUPPORT) DIRECTED THE CUSTOMER TO POWER DOWN AND EMPTY THE BOTTLE. THE CUSTOMER REINSTALLED THE OVERFLOW BOTTLE AND PRIMED THE CTA. THE CUSTOMER OBSERVED THAT THE LATCH BAR ON THE PERIPUMP ASSEMBLY WAS NOT TIGHTENED DOWN. CTS DIRECTED THE CUSTOMER TO MOVE IT IN PLACE AND TIGHTEN IT DOWN. CTS DIRECTED THE CUSTOMER TO PRIME THE INSTRUMENT 3 TIMES AND TOLD CUSTOMER TO OBSERVE THE OVERFLOW BOTTLE THROUGHOUT THE DAY AND CALL BACK IF IT STARTED TO FILL UP AGAIN. CTS CALLED CUSTOMER TO CHECK ON THE STATUS OF THE INSTRUMENT. CUSTOMER VERIFIED THE OVERFLOW BOTTLE HAD NO FLUID IN IT AND LIFTED THE COVER TO OBSERVE FOR LEAKS BELOW THE WASH CUP. NO LEAKS WERE NOTED. ISSUE WAS RESOLVED THROUGH TROUBLESHOOTING WITH CTS. CUSTOMER HAS NOT CALLED BACK FOR ASSISTANCE WITH THIS ISSUE. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BEC) REGARDING A LEAK UNDER THE CLOSED TUBE ALIQUOTTER (CTA) OF UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM. THE CUSTOMER OPENED THE DOOR AND OBSERVED THE OVERFLOW BOTTLE WAS FULL. NO INJURY WAS REPORTED AND NO ERRONEOUS RESULTS WERE GENERATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL® DXC 600I SYNCHRON® ACCESS® CLINICAL SYSTEM CLINICAL CHEMISTRY ANALYZER JJE BECKMAN COULTER INC. DXC 600I NA

    Patients

    Seq Age Sex Outcome Treatment
    1