BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 800 PRO SYNCHRON® CLINICAL SYSTEM

    MDR report key: 2052341 · Received April 12, 2011

    Report

    Report Number
    2050012-2011-01084
    Event Type
    Malfunction
    Date Received
    April 12, 2011
    Date of Event
    March 14, 2011
    Report Date
    March 14, 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
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BCI FIELD SERVICE ENGINEER (FSE) WAS ON SITE ON (B)(6) 2011. THE FSE FOUND A BLOCKAGE IN A QUICK DISCONNECT FITTING CONNECTED TO LINE 180. THE FSE CLEARED THE BLOCKAGE AND VACUUM WAS RESUMED.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) IN REGARDS TO A FLUID LEAK IN THE CAP PIERCER AREA ON UNICEL DXC 800 PRO SYNCHRON CLINICAL SYSTEM. THE CUSTOMER STATED THE FLUID APPEARED TO BE WASH SOLUTION. NO INJURY WAS REPORTED, AND THERE WAS NO EFFECT TO PATIENT OR USERS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL® DXC 800 PRO SYNCHRON® CLINICAL SYSTEM CLINICAL CHEMSTRY ANALYZER JJE BECKMAN COULTER, INC. DXC 800 PRO NA

    Patients

    Seq Age Sex Outcome Treatment
    1