BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL DXC 800 SYNCHRON SYSTEM

    MDR report key: 2391121 · Received December 28, 2011

    Report

    Report Number
    2050012-2011-08580
    Event Type
    Malfunction
    Date Received
    December 28, 2011
    Date of Event
    November 30, 2011
    Report Date
    November 30, 2011
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    K042291
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE BECKMAN COULTER, INC. IDENTIFIER FOR THIS REPORT IS (B)(4).

    Description of Event or Problem · 1

    CUSTOMER CALLED TO REPORT THAT WHILE PERFORMING MAINTENANCE, THE ALBUMIN CUP ON THE UNICEL DXC 800 SYNCHRON SYSTEM WAS OVERFLOWING. THE CUSTOMER TECHNICAL SPECIALIST (CTS) SCHEDULED A SERVICE VISIT. THE FIELD SERVICE ENGINEER (FSE) INSPECTED THE INSTRUMENT AND NOTICED EVIDENCE OF THE OVERFLOW ON THE BACK PANEL UNDERNEATH THE CARTRIDGE CHEMISTRY (CC) SAMPLE SYRINGE. THE FSE THEN FOUND THAT THE CC SAMPLE SYRINGE T-VALVE WAS LEAKING. THE FSE REPLACED THE T-VALVE, AFTER WHICH NO FURTHER EVIDENCE OF LEAKING WAS OBSERVED. THE FSE THEN PERFORMED PREVENTIVE MAINTENANCE AND VERIFIED INSTRUMENT PERFORMANCE TO ENSURE THAT THE SERVICES PERFORMED EFFECTIVELY RESOLVED THE INSTRUMENT ISSUE. DURING THE VISIT, THE FSE DID NOT FIND THAT THE ALBUMIN CUP WAS OVERFLOWING. UPON FURTHER FOLLOW UP, THE FSE STATED THAT CUSTOMER MISTAKENLY CHARACTERIZED THE EVIDENCE OF OVERFLOW ON THE BACK PANEL UNDERNEATH THE CC SAMPLE SYRINGE AS AN ALBUMIN CUP OVERFLOW. THE ACTUAL SOURCE OF THE OVERFLOW WAS THE CC SAMPLE SYRINGE FROM THE T-VALVE. CUSTOMER STATED THAT PATIENT SAMPLE RESULTS WERE NOT AFFECTED, AND THAT NO ONE WAS HARMED BY OR EXPOSED TO THE LEAK.

    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