BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 600I SYNCHRON ® CHEMISTRY ANALYZER

    MDR report key: 2140234 · Received June 26, 2011

    Report

    Report Number
    2050012-2011-02640
    Event Type
    Malfunction
    Date Received
    June 26, 2011
    Date of Event
    May 26, 2011
    Report Date
    May 26, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJE
    PMA / PMN Number
    K060256
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER STATED RED LINE TUBING HAD POPPED OFF. ON(B)(6) 2011 A BCI FIELD SERVICE ENGINEER (FSE) FOUND THE REMAINS OF A LARGE LEAK ON THE INSIDE OF THE INSTRUMENT AND DETERMINED THAT THE WASTE TUBING FROM THE ACTIVE WASH TOWER WAS UNSCREWED FROM THE TOWER. FSE SCREWED THE TUBING INTO WASH TOWER AND ENSURED ALL OTHER TUBINGS WERE SECURE. FSE CLEANED INSIDE OF THE CTA AND PRIMED THE INSTRUMENT 20 TIMES WITH NO LEAKS. THE INSTRUMENT WAS OPERATIONAL.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) HOTLINE TO REPORT THE CLOSE TUBE ACCESSION (CTA) WAS FLOODED ON THE INSIDE OF THE INSTRUMENT AND ONTO THE FRONT OF THE INSTRUMENT. NO INJURY OR FUMES WERE REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1