BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 600 PRO SYNCHRON® CHEMISTRY ANALYZER

    MDR report key: 2091498 · Received May 17, 2011

    Report

    Report Number
    2050012-2011-01806
    Event Type
    Malfunction
    Date Received
    May 17, 2011
    Date of Event
    April 16, 2011
    Report Date
    April 16, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJE
    PMA / PMN Number
    K042291
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER TECHNICAL SUPPORT (CTS) DIRECTED THE CUSTOMER TO RESEAT THE FLOAT SWITCH CABLE AND THEN HOME THE INSTRUMENT. PER THE CUSTOMER, THE ERROR MESSAGES WENT AWAY. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED AND PERFORMED SERVICE ON THE INSTRUMENT. THE FSE FOUND A HOLE IN THE CAP PIERCER PERI PUMP TUBING. THE FSE REPLACED THE TUBING AND PRIMED. THE FSE ALSO OBSERVED A LEAK AT THE WASH CONCENTRATE CANISTER AND DETERMINED THAT A FITTING WAS LOOSE. THE FSE REPLACED THE FITTING AND PRIMED THE INSTRUMENT. THE FSE PERFORMED QC AND NO FURTHER ERRORS OR LEAKS WERE OBSERVED.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) STATING THAT THE UNICEL DXC 600 PRO SYNCHRON CHEMISTRY ANALYZER WAS GENERATING HYDRO SWITCH ERRORS AND "WASH CONCENTRATE CANISTER DID NOT FILL IN TIME" MESSAGES. CUSTOMER ALSO REPORTED THAT THE WASH CONCENTRATE CANISTER HAD LEAKED AND CRUSTED AROUND THE CAP AND THE FLOAT SWITCH CABLES. THE CUSTOMER ALSO REPORTED THAT THE AUTOGLOSS WAS NOT BEING DELIVERED. NO INJURY OR OPERATOR EXPOSURE WAS REPORTED IN THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL® DXC 600 PRO SYNCHRON® CHEMISTRY ANALYZER CLINICAL CHEMISTRY ANALYZER JJE BECKMAN COULTER INC. DXC 600 PRO N/A

    Patients

    Seq Age Sex Outcome Treatment
    1