BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHRON LX® I 725 CLINICAL SYSTEM

    MDR report key: 2077161 · Received May 4, 2011

    Report

    Report Number
    2050012-2011-01444
    Event Type
    Malfunction
    Date Received
    May 4, 2011
    Date of Event
    April 4, 2011
    Report Date
    April 4, 2011
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    K023049
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BCI FIELD SERVICE ENGINEER (FSE) DETERMINED THAT THE WASH TOWER VACUUM VALVE WAS FAILING INTERMITTENTLY AND THE VACUUM PROBE TUBING WAS CRACKED. TDM (THERAPEUTIC DRUG MONITOR) QC WAS STILL HIGH AFTER CALIBRATION, ALTHOUGH OTHER CALIBRATIONS AND QC WERE GOOD. THE FSE REPLACED PHOTOMETER AND NUMEROUS BUBBLE GENERATOR VALVES BUT PROBLEM DID NOT RESOLVE. FURTHER TROUBLESHOOTING REVEALED A DEFECTIVE Y CONNECTOR ON THE DEGASSER ASSEMBLY, WHICH WAS RESTRICTING WATER FLOW TO BUBBLE GENERATOR. FSE VERIFIED REPAIRS PER ESTABLISHED PROCEDURES.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) IN REGARDS TO QC FAILURES ON THE CARTRIDGE CHEMISTRY SIDE AND FLUID LEAKS ON SYNCHRON LXI 725 CLINICAL SYSTEM. THE CUSTOMER OBSERVED A DRY WHITE CRUSTY SUBSTANCE ON THE BLACK TRAY BELOW THE REAGENT PROBE AND SOME LIQUID ON THE TRAY AFTER CLEANING THE DRY SUBSTANCE. THE CUSTOMER ALSO REPORTED CUVETTE NOT DRY ERRORS. THERE WAS NO EFFECT TO PATIENT OR USER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHRON LX® I 725 CLINICAL SYSTEM CLINICAL CHEMSTRY ANALYZER JJE BECKMAN COULTER, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1