BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 600I SYNCHRON® ACCESS® CLINICAL SYSTEM

    MDR report key: 2130894 · Received June 16, 2011

    Report

    Report Number
    2050012-2011-02373
    Event Type
    Malfunction
    Date Received
    June 16, 2011
    Date of Event
    May 6, 2011
    Report Date
    May 6, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJE
    PMA / PMN Number
    K060256
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE FIELD SERVICE ENGINEER (FSE) CLEANED THE SPILLS AND THE REACTION VESSELS (RVS). THE ROOT CAUSE IS CURRENTLY UNDER INVESTIGATION.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) STATING THAT DURING A SERVICE CALL, THE FIELD SERVICE ENGINEER (FSE) NOTICED THAT THE USED WASTE REACTION VESSELS (RVS) WERE NOT FALLING INTO THE WASTE BIN AND WERE COLLECTED UNDER THE CLOSED TUBE ALIQUOTER (CTA). SERVICE STATED THAT THE RVS BEING EJECTED ARE NOT TRAVELING DOWN THE FULL LENGTH OF THE CHUTE AND ARE NOT LANDING INSIDE THE SOLID WASTE BIN DESPITE THE LID OF THE BIN BEING REMOVED AND WASTE BAG BEING FULLY INSERTED CORRECTLY. NO INJURY OR OPERATOR EXPOSURE WAS REPORTED FOR THIS EVENT.

    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 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1