BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 600I SYNCHRON® ACCESS® CLINICAL SYSTEM

    MDR report key: 2313207 · Received October 28, 2011

    Report

    Report Number
    2050012-2011-06551
    Event Type
    Malfunction
    Date Received
    October 28, 2011
    Date of Event
    September 29, 2011
    Report Date
    September 29, 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
    CA, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    A FIELD SERVICE ENGINEER (FSE) WENT ON-SITE (B)(4) 2011 AND NOTED WASH SOLUTION CANISTER NOT FILLING ERRORS FOLLOWED BY PRESSURE ERRORS AND WASH CONCENTRATE BOTTLE OVERFLOW. FSE REPLACED WASH SOLUTION CANISTER FLOAT SWITCH AND PRIMED INSTRUMENT TO VERIFY THAT CANISTER WAS PROPERLY FILLING AND DRAINING. REPAIR WAS VERIFIED PER ESTABLISHED PROCEDURES AND RESULTS MET PUBLISHED PERFORMANCE SPECIFICATIONS. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BEC) REPORTING THAT THE WASH CONCENTRATE BOTTLE IN THE UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM WAS OVERFLOWING AND LEAKING. NO INJURY OR EXPOSURE WAS REPORTED AND NO ERRONEOUS RESULTS WERE GENERATED.

    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 NA

    Patients

    Seq Age Sex Outcome Treatment
    1