BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 600 PRO SYNCHRON® CLINICAL SYSTEM

    MDR report key: 1979650 · Received February 5, 2011

    Report

    Report Number
    2050012-2011-00374
    Event Type
    Malfunction
    Date Received
    February 5, 2011
    Date of Event
    January 7, 2011
    Report Date
    January 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
    MA, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    SERVICE VISITED ON (B)(4) 2011, AND FOUND EXCESS LIQUID ON CAPS FROM CAP PIERCER. THE FIELD SERVICE ENGINEER (FSE) INSPECTED HARDWARE COMPONENTS. WASTE VALVE WAS WORKING AND THERE WAS NO VISIBLE DAMAGE TO PLASTIC OR O-RINGS. THE FSE REPLACED A FEW HARDWARE COMPONENTS. THE FSE PRIMED THE INSTRUMENT 100 TIMES AND NO LEAK WAS OBSERVED. THE INSTRUMENT RESUMED OPERATION.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER, INC. (BCI) IN REGARDS TO A LEAK ON UNICEL DXC 600 PRO SYNCHRON CLINICAL SYSTEM. THE CUSTOMER STATED THE CAP PIERCER IS LEAKING AUTO GLOSS/WASH CONCENTRATE SOLUTION AT THE WICK/DRAIN. THE CUSTOMER CHANGED THE WICK BUT THE LEAK CONTINUED. NO INJURY WAS REPORTED AND THERE WAS NO EFFECT TO PATIENT OR USER.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1