BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 600 PRO SYNCHRON® CHEMISTRY ANALYZER

    MDR report key: 2232130 · Received September 2, 2011

    Report

    Report Number
    2050012-2011-04758
    Event Type
    Malfunction
    Date Received
    September 2, 2011
    Date of Event
    August 2, 2011
    Report Date
    August 2, 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
    FL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED ON (B)(6) 2011 AND REPLACED THE CO2 MEMBRANE, QUAD RINGS, AND ELECTRODE. ISE WAS CALIBRATED WITH SATISFACTORY RESULTS. REPAIRS WERE VERIFIED PER ESTABLISHED PROCEDURES PRIOR TO RETURNING IT INTO SERVICE. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BEC) REPORTING THAT A LEAK WAS OBSERVED FROM THE FLOW CELL AFTER THE CARBON DIOXIDE (CO2) MEASURING ELECTRODE WAS REPLACED. CUSTOMER TECHNICAL SUPPORT (CTS) DETERMINED THAT THE CUSTOMER HAD NOT PUT A MEMBRANE ON THE CO2 ELECTRODE PRIOR TO INSTALLING THE ELECTRODE; CUSTOMER WAS NOT AWARE THAT A MEMBRANE WAS REQUIRED ON THE CO2 ELECTRODE AND ONLY INSTALLED A RETAINER AND QUADRING ON THE ELECTRODE. NO INJURY OR OPERATOR EXPOSURE WAS REPORTED FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL® DXC 600 PRO SYNCHRON® CHEMISTRY ANALYZER CLINICAL CHEMISTRY ANALYZER JJE BECKMAN COULTER INC. DXC 600 PRO NA

    Patients

    Seq Age Sex Outcome Treatment
    1