BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM

    MDR report key: 4171578 · Received October 14, 2014

    Report

    Report Number
    2050012-2014-00466
    Event Type
    Malfunction
    Date Received
    October 14, 2014
    Date of Event
    September 23, 2014
    Report Date
    September 23, 2014
    Manufacturer
    BECKMAN COULTER
    Product Code
    JJE
    PMA / PMN Number
    K060256
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO EVALUATE THE INSTRUMENT AND CONFIRMED LEAKING FROM THE CAP PIERCER BLADE WASH STATION. THE FSE FOUND THE CAUSE OF THE LEAK WAS AN OBSTRUCTION OF RUBBER SAMPLE TUBE CAPS IN THE CAP PIERCER DRAIN TUBE LINE #118. THE FSE REMOVED THE OBSTRUCTION FROM THE DRAIN TUBE LINE TO RESOLVE THE ISSUE, NO FURTHER LEAKING WAS OBSERVED. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A LEAK FROM THE CAP PIERCER ON A UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM. THE CUSTOMER STATED THE LEAK WAS CONTAINED TO THE INSTRUMENT AND A SERVICE REQUEST WAS INITIATED. NO ERRONEOUS RESULTS WERE GENERATED. THE OPERATOR WAS WEARING PERSONAL PROTECTIVE EQUIPMENT AND NO INJURY OR EXPOSURE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    649936 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