BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 600 SYNCHRON® CLINICAL SYSTEM (PACKAGED)

    MDR report key: 2232114 · Received September 1, 2011

    Report

    Report Number
    2050012-2011-04974
    Event Type
    Malfunction
    Date Received
    September 1, 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
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A FIELD SERVICE ENGINEER (FSE) WENT ON-SITE (B)(6) 2011 AND FOUND THAT LEAK WAS COMING FROM A VALVE IN THE HYDROPNEUMATIC VALVE MODULE. FSE REPLACED THE VALVE, THE REGULATOR AND THE DI (DEIONIZED) FLOAT SWITCH. FSE PRIMED UNIT 20 TIMES AND NO LEAK WAS OBSERVED. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BEC) REGARDING A LEAK THAT WAS OBSERVED ON THE FLOOR UNDERNEATH THE UNICEL DXC 600 SYNCHRON CLINICAL SYSTEM. THE CUSTOMER OPENED HYDROPNEUMATIC DRAWER AND OBSERVED LEAKED MATERIAL IN LEFT FRONT OF HYDROPNEUMATIC COMPARTMENT. NATURE OF THE LEAKED MATERIAL WAS UNKNOWN. NO INJURY OR EXPOSURE WAS REPORTED AND NO ERRONEOUS PATIENT RESULTS WERE GENERATED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1