BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM

    MDR report key: 3990277 · Received August 7, 2014

    Report

    Report Number
    2050012-2014-00372
    Event Type
    Malfunction
    Date Received
    August 7, 2014
    Date of Event
    July 15, 2014
    Report Date
    July 15, 2014
    Manufacturer
    BECKMAN COULTER
    Product Code
    JJE
    PMA / PMN Number
    K060256
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A BECKMAN COULTER (BEC) FIELD SERVICE ENGINEER (FSE) EVALUATED THE INSTRUMENT AND DETERMINED THE CAP PIERCER DRAIN LINE, #118, WAS OBSTRUCTED. THE FSE FLUSHED THE LINE TO CORRECT THE PROBE OBSTRUCTION ERRORS AND THE LEAK FROM THE BLADE WASH AREA OF THE CAP PIERCER. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED TO BECKMAN COULTER (BEC) HOTLINE SUPPORT THAT THEIR UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM GENERATED "CARTRIDGE CHEMISTRY SAMPLE PROBE OBSTRUCTION" ERRORS. UPON TROUBLESHOOTING THE ERRORS WITH BEC HOTLINE SUPPORT, THE CUSTOMER STATED THEY DISCOVERED A LEAK FROM THE CAP PIERCER BLADE WASH AREA OF THE INSTRUMENT. THE CUSTOMER WORE GLOVES AND A LAB WHILE TROUBLESHOOTING. ERRONEOUS PATIENT RESULTS WERE NOT GENERATED AND THERE WAS NO CHANGE OR AFFECT TO PATIENT TREATMENT IN CONNECTION WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    464314 UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1