BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 600 SYNCHRON® SYSTEM

    MDR report key: 3671729 · Received March 11, 2014

    Report

    Report Number
    2050012-2014-00137
    Event Type
    Malfunction
    Date Received
    March 11, 2014
    Date of Event
    February 18, 2014
    Report Date
    February 18, 2014
    Manufacturer
    BECKMAN COULTER
    Product Code
    JJE
    PMA / PMN Number
    K042291
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED. THE FSE REPLACED THE HAMILTON HV 4-4 VALVE (P/N 970835) TO RESOLVE THE ISSUE. HE ALSO REPLACED THE T-VALVE, SOLENOID VALVE, AND LEVEL SENSE ASSEMBLY AS PRECAUTIONARY MEASURES. (B)(4).

    Additional Manufacturer Narrative · 1

    PARTS REPLACED WERE RETURNED FOR INVESTIGATION. THE PARTS RECEIVED WERE: 970835 - HV 4-4 VALVE (HAMILTON), 758419 - T-VALVE ASSEMBLY, 472689 - VALVE-SOLENOID, A20501- LEVEL SENSE ASSEMBLY. THE TESTING OF THESE PARTS REVEALED THE SOLENOD VALVE REV. A (P/N 472689) WAS THE CAUSE OF THE LEAKING FROM REAGENT PROBE A. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A CONTAINED REAGENT PROBE A LEAK ON A UNICEL DXC 600 PRO INSTRUMENT. THE CUSTOMER STATED REAGENT PROBE A WAS LEAKING FLUID INTO THE DRIP WELL ON TH REACTION WHEEL COVER. THE CUSTOMER STATED THE FLUID WAS CONTAINED TO THE INSTRUMENT AND APPEARED TO BE WASH SOLUTION. NO ERRONEOUS PATIENT RESULTS WERE GENERATED IN CONNECTION WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    145243 UNICEL® DXC 600 SYNCHRON® SYSTEM ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1