BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL DXC 800 SYNCHRON SYSTEM

    MDR report key: 2504466 · Received March 26, 2012

    Report

    Report Number
    2050012-2012-00836
    Event Type
    Malfunction
    Date Received
    March 26, 2012
    Date of Event
    March 2, 2012
    Report Date
    March 2, 2012
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    K042291
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE ROOT CAUSE OF THE ISSUE IS ATTRIBUTED TO THE CLOT IN THE ODC. THE ISSUE WAS RESOLVED WHEN THE FIELD SERVICE ENGINEER REPLACED THE ODC. CUSTOMER HAS NOT CALLED BACK TO REPORT ANY FURTHER ISSUES RELATING TO THIS EVENT. (B)(4).

    Description of Event or Problem · 1

    CUSTOMER CALLED TO REPORT THAT THE MODULAR CHEMISTRY (MC) OBSTRUCTION DETECTOR OF THE UNICEL DXC 800 SYNCHRON SYSTEM WAS LEAKING. CUSTOMER WAS WEARING PERSONAL PROTECTIVE EQUIPMENT (PPE) CONSISTING OF A LABORATORY COAT AND GLOVES. CUSTOMER DID NOT COME IN CONTACT WITH THE FLUID, AND MEDICAL ATTENTION WAS NOT SOUGHT. THERE WAS NO REPORT OF EXPOSURE TO MUCOUS MEMBRANES OR OPEN WOUNDS, AND NO ONE WAS SPLASHED OR SPRAYED. THERE WAS NO DEATH, INJURY OR CHANGE TO PATIENT TREATMENT ATTRIBUTED TO OR ASSOCIATED WITH THIS COMPLAINT. THERE WAS NO IMPACT TO PATIENT SAMPLES OR RESULTS. THE FIELD SERVICE ENGINEER (FSE) INSPECTED THE INSTRUMENT AND FOUND THAT THE ODC (OBSTRUCTION DETECTOR) HAD BLOWN OUT DUE TO A CLOT. THE FSE REPLACED THE ODC, THE MC COLLAR AND THE MC PROBE. THE FSE THEN VERIFIED PROPER INSTRUMENT PERFORMANCE TO ENSURE THAT THE SERVICES PERFORMED EFFECTIVELY RESOLVED THE INSTRUMENT ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL DXC 800 SYNCHRON SYSTEM ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE BECKMAN COULTER, INC. DXC 800 PRO

    Patients

    Seq Age Sex Outcome Treatment
    1