BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 600 PRO SYNCHRON® CLINICAL SYSTEMS

    MDR report key: 2103578 · Received May 26, 2011

    Report

    Report Number
    2050012-2011-01922
    Event Type
    Malfunction
    Date Received
    May 26, 2011
    Date of Event
    April 29, 2011
    Report Date
    April 29, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJE
    PMA / PMN Number
    K042291
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PER CUSTOMER, THE RUBBER CAPS HAD A Z CUT, BUT "CHUNKS OF IT MISSING". CTS DIRECTED CUSTOMER TO INSPECT THE BLADE AND IT WAS NOT BENT; WICK INSPECTED AND APPEARED "DIRTY". A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED. THE FSE DISASSEMBLED THE WASH AREA AND CLEANED AND BACK-FLUSHED THE VACUUM LINE. THE FSE REPLACED THE 3-WAY VALVE AND VERIFIED REPAIRS PER ESTABLISHED PROCEDURES.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) AND REPORTED TO CUSTOMER TECHNICAL SUPPORT (CTS) THAT THEY WERE GETTING MC/CC OBSTRUCTION DETECTION ERRORS ON THE UNICEL DXC 600 PRO SYNCHRON CLINICAL SYSTEM, AND THERE WAS A POOL OF FLUID ON THE TUBES WHEN THEY WERE OFF LOADED. NO INJURY WAS REPORTED ON THIS ISSUE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1