BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC SYNCHRON ® CHEMISTRY ANALYZER

    MDR report key: 2233827 · Received September 4, 2011

    Report

    Report Number
    2050012-2011-05080
    Event Type
    Malfunction
    Date Received
    September 4, 2011
    Date of Event
    August 4, 2011
    Report Date
    August 4, 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
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ON (B)(4) 2011, A BEC FIELD SERVICE ENGINEER (FSE) PERFORMED SERVICE ON THE INSTRUMENT: FSE EMPTIED THE AIR WATER SEPARATOR AND CLEANED THE WASTE CANISTER. SETTING WAS ADJUSTED ON A WASTE FLOAT SWITCH TO ALLOW FOR PROPER DRAINAGE. REPAIR VERIFIED PER ESTABLISHED PROCEDURES. ISSUE WAS RESOLVED BY A ROUTINE SERVICE REPAIR. BEC INTERNAL NOTIFICATION NUMBER IS (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED BECKMAN COULTER INC. (BEC) CUSTOMER TECHNICAL SUPPORT (CTS) TO REPORT A HYDRO ERROR AND FOUND THE HYDRO DRAWER FULL OF LIQUID. THE CUSTOMER WAS WEARING PERSONAL PROTECTIVE EQUIPMENT DURING THE EVENT. PER CUSTOMER, ABOUT 1 LITER LEAKED ONTO FLOOR. CTS DISCUSSED HOW TO EMPTY THE WASTE CONTAINERS THAT WERE FULL AND THEN HOME THE INSTRUMENT. CTS GENERATED A SERVICE REQUEST. NO INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL® DXC SYNCHRON ® CHEMISTRY ANALYZER DISCRETE PHOTOMETRIC CHEMISTRY ANALYZER FOR CLINICAL USE JJE BECKMAN COULTER INC. DXC 800 PRO N/A

    Patients

    Seq Age Sex Outcome Treatment
    1