BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHRON LX®I 725 SYSTEM

    MDR report key: 3062245 · Received April 16, 2013

    Report

    Report Number
    2050012-2013-00253
    Event Type
    Malfunction
    Date Received
    April 16, 2013
    Date of Event
    March 25, 2013
    Report Date
    March 25, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    JJE
    PMA / PMN Number
    K023049
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER DISCOVERED EXCESSIVE FLUID ON TOP OF THE SAMPLE TUBE CAPS INVOLVING THE SYNCHRON LXI 725 SYSTEM. THE CUSTOMER ALSO REPORTED A SMALL AMOUNT OF FLUID INSIDE THE INSTRUMENT COMING FROM THE CLOSED-TUBE ALIQUOTER (CTA). THE CUSTOMER WAS WEARING PERSONAL PROTECTIVE EQUIPMENT AT THE TIME OF THE EVENT AND THE LABORATORY HAS AN EXPOSURE CONTROL PLAN IN PLACE. NO PATIENT RESULTS WERE AFFECTED AND THERE WAS NO CHANGE OR AFFECT TO PATIENT TREATMENT IN CONNECTION WITH THIS EVENT. A BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED AND DISCOVERED A PIECE OF CAP STUCK IN THE CHECK VALVE OF THE DRAIN LINE. THE FSE REMOVED THE PIECE OF CAP FROM THE CHECK VALVE TO RESOLVE THE ISSUE. REPAIR WAS VERIFIED AND RESULTS MET PUBLISHED SPECIFICATIONS. FAILURE MODE IS ATTRIBUTED TO A CLOGGED CHECK VALVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    162908 SYNCHRON LX®I 725 SYSTEM ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1