BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 800 PRO SYNCHRON® CLINICAL SYSTEMS

    MDR report key: 2083192 · Received May 10, 2011

    Report

    Report Number
    2050012-2011-01538
    Event Type
    Malfunction
    Date Received
    May 10, 2011
    Date of Event
    April 11, 2011
    Report Date
    April 11, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJE
    PMA / PMN Number
    K042291
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED ON (B)(4) 2011: THE FSE CHANGED ION SELECTIVE ELECTRODE (ISE) VALVES AND FOUND THE VACUUM WAS LOW IN WASTE TUBING 15 DUE TO A PINCH IN THE TUBING CLAMP. THE FSE REPLACED THE TUBING AND THE VACUUM WAS WITHIN SPECIFICATIONS. THE FSE PRIMED THE ISE AND EIC AND NO OVERFLOW WAS DETECTED. CALIBRATION AND QC WERE ACCEPTABLE. HARDWARE IS THE ROOT CAUSE FOR THIS EVENT.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) AND REPORTED THAT THEIR ELECTROLYTE INJECTION CUP (EIC) WAS OVERFLOWING ON UNICEL DXC 800 PRO SYNCHRON CLINICAL SYSTEM AND THEY HAD PROBLEM WITH QC. A CUSTOMER TECHNICAL SUPPORT (CTS) DIRECTED CUSTOMER TO DISASSEMBLE AND CLEAN EIC AND INSPECT VALVES PER IFU. CUSTOMER COMPLETED TROUBLESHOOTING RECOMMENDED BY CTS, BUT CONTINUED TO SEE OVERFLOWING DURING BUFFER PRIME. CTS GENERATED A SERVICE REQUEST FOR CUSTOMER. NO INJURY WAS REPORTED ON THIS ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL® DXC 800 PRO SYNCHRON® CLINICAL SYSTEMS CLINICAL CHEMISTRY ANALYZER JJE BECKMAN COULTER INC. DXC 800 PRO N/A

    Patients

    Seq Age Sex Outcome Treatment
    1