BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    4D INTEGRATED TREATMENT CONSOLE

    MDR report key: 2232523 · Received July 19, 2011

    Report

    Report Number
    2916710-2011-00089
    Event Type
    Malfunction
    Date Received
    July 19, 2011
    Date of Event
    April 22, 2011
    Report Date
    April 22, 2011
    Manufacturer
    VARIAN MEDICAL SYSTEMS
    Product Code
    IYE
    PMA / PMN Number
    K091132
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIST

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INVESTIGATION DETERMINED THAT NO MIS-ADMINISTRATION OCCURRED. THIS IS A KNOWN ISSUE WHICH HAS BEEN PREVIOUSLY INVESTIGATED AND REPORTED. DELIVERY OF A RAPID ARC PLAN AS A DYNAMIC ARC AT THE 4DITC SHOWS A SUBOPTIMAL DOSE DISTRIBUTION THAT COULD HAVE RESULTED IN LOSS OF TUMOR CONTROL AND / OR HIGHER THAN INTENDED DOSES TO OTHER CRITICAL TISSUES. THE PLANS SUBMITTED BY THE USER SHOWED DOSE DIFFERENCES OF UP TO 15%, BUT HIGHER ERRORS COULD OCCUR USING THE V8.6 / V8.8 ALGORITHM. FROM THE ABOVE IMPLEMENTATION, IT IS CLEAR THAT 4DITC 8.8 IDENTIFIES AS RAPIDARC IF THE DOSE RATE DIFFERENCE BETWEEN ANY CONSECUTIVE CONTROL POINTS ARE GREATER THAN DEFINED TOLERANCE, WHERE AS IN 4DITC 10, IT CHECKS THE DIFFERENCE BETWEEN MINIMUM DOSE RATE AND MAXIMUM DOSE RATE, IF THE DIFFERENCE IS GREATER THAN THE DEFINED TOLERANCE THEN IT IDENTIFIES AS RAPIDARC. THE ISSUE AFFECTS ONLY ECLIPSE V 8.5 OR THIRD PARTY RA PLANS TREATED USING 4DITC 8.6 / 8.8. NO INJURIES HAVE BEEN REPORTED TO DATE. A CAPA HAS BEEN INITIATED TO ADDRESS THIS ISSUE. A PRODUCT NOTIFICATION LETTER WILL BE SENT TO AFFECTED CUSTOMERS. ALL CORRECTIVE ACTION WILL BE REPORTED UNDER THE GUIDELINES OF 21 CFR PART 806. NO FOLLOW-UP REPORTS ARE ANTICIPATED. SEE SCANNED PAGES.

    Description of Event or Problem · 1

    RAPID ARC PLAN INTERPRETED AS CONFORMAL ARC AT 4DITC. THE CUSTOMER REPORTS THAT THE BOOST PLAN RAPID ARC FIELDS DO NOT HAVE THE "R" ICON FOR THE TREATMENT FIELDS, WHEN MODED UP AT 4DITC. THE CUSTOMER REPORTS THAT THE PATIENT WAS THEN TREATED WITH THIS PLAN, AS A CONFORMAL ARC. THE QA FROM PHYSICS WAS OK BUT ALSO, DID NOT HAVE THE "R." ADDITIONAL INVESTIGATION DETERMINED THAT NO MIS-ADMINISTRATION OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 4D INTEGRATED TREATMENT CONSOLE ACCELERATOR, LINEAR, MEDICAL IYE VARIAN MEDICAL SYSTEMS H51

    Patients

    Seq Age Sex Outcome Treatment
    1