BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM

    MDR report key: 2073384 · Received May 1, 2011

    Report

    Report Number
    2050012-2011-01295
    Event Type
    Malfunction
    Date Received
    May 1, 2011
    Date of Event
    March 31, 2011
    Report Date
    March 31, 2011
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    K060256
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER DISABLED CAP PIERCER ASSEMBLY. SERVICE VISITED ON (B)(4) 2011, AND THE FIELD SERVICE ENGINEER (FSE) FOUND VACUUM WAS SLUGGISH WHEN EVACUATING CAP PIERCER. THE STANDBY SYSTEM VACUUM WAS WITHIN SPECIFICATIONS. THE FSE FLUSHED THE LINE WITH LARGE AMOUNT OF HOT WATER AND BLEACH AND VACUUM IMMEDIATELY IMPROVED. THE FSE CLEANED BLADE WASH TOWER AND NOTICED SOME SMALL CRACKS CAUSING A VERY SMALL AMOUNT OF FLUID TO CONTACT SCREWS IN TOWER. THE FSE REPLACED THE CAP PIERCER WASH TOWER, AND THIS ISSUE WAS RESOLVED.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER, INC. (BCI) IN REGARDS TO A FLUID LEAK FROM UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM. THE CUSTOMER STATED THAT FLUID FROM CAP PIERCER WAS LEAKING ONTO CAPPED TUBES, AND THAT CAP PIERCER BLADE WASH CUP MAYBE LEAKING OR OVERFLOWING. THERE WAS NO EFFECT TO PATIENT OR USER.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1