BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 600 PRO SYNCHRON® CLINICAL SYSTEM

    MDR report key: 2221899 · Received August 24, 2011

    Report

    Report Number
    2050012-2011-04742
    Event Type
    Malfunction
    Date Received
    August 24, 2011
    Date of Event
    February 7, 2011
    Report Date
    February 7, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJE
    PMA / PMN Number
    K042291
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A FIELD SERVICE ENGINEER WAS ON-SITE AND REPLACED THE LOW PRESSURE REGULATOR AND THE CC SAMPLE COLLAR WASH VALVE. FOR THE LOW VACUUM ERRORS, THE VACUUM PUMP AND VACUUM/PRESSURE PUMP WAS REPLACED. FSE PRIMED INSTRUMENT MULTIPLE TIMES WITH NO LEAKS OR ERRORS. THE BEC INTERNAL IDENTIFIER FOR THIS EVENT IS (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BEC) STATING THAT THE UNICEL DXC 600 PRO SYNCHRON CLINICAL SYSTEM WAS LEAKING WATER OUT OF THE LOW PRESSURE VALVE AND THE DI WATER CANISTER WAS FULL. THE CC SAMPLE PROBE WAS ALSO LEAKING AND THE INSTRUMENT WAS GIVING LOW VACUUM ERRORS. NO INJURY WAS REPORTED AND NO ERRONEOUS RESULTS WERE GENERATED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1