BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 880I SYNCHRON® ACCESS® CLINICAL SYSTEMS

    MDR report key: 2103576 · Received May 26, 2011

    Report

    Report Number
    2050012-2011-01923
    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
    K060256 RR
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A FIELD SERVICE ENGINEER (FSE) EMPTIED LIQUID FROM THE VACUUM ACCUMULATOR AND DRAINED THE MICRO MIST SEPARATORS. THE FSE VERIFIED VACUUM MET SPECIFICATIONS.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) AND REPORTED THAT THEY WERE GETTING A FLOOD IN PRIMARY VACUUM ACCUMULATOR IN UNICEL DXC 880I SYNCHRON ACCESS CLINICAL SYSTEM. A CUSTOMER TECHNICAL SERVICE (CTS) DIRECTED CUSTOMER TO CHECK CANISTERS AND CUSTOMER STATED THE PRIMARY VACUUM ACCUMULATOR WAS FULL OF FLUID. CUSTOMER WAS ADVISED TO REMOVE, CLEAN AND REINSTALL THE CANISTER. NO INJURY WAS REPORTED IN CONNECTION WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL® DXC 880I SYNCHRON® ACCESS® CLINICAL SYSTEMS DISCRETE PHOTOMETRIC CHEMISTRY ANALYZER JJE BECKMAN COULTER INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1