BEUDAMED
    FDA Adverse Event Injury Summary report: N

    4D INTEGRATED TREATMENT CONSOLE

    MDR report key: 1820566 · Received August 25, 2010

    Report

    Report Number
    2916710-2010-00100
    Event Type
    Injury
    Date Received
    August 25, 2010
    Date of Event
    July 30, 2010
    Report Date
    July 30, 2010
    Manufacturer
    VARIAN MEDICAL SYSTEMS
    Product Code
    IYE
    PMA / PMN Number
    K050479
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE INITIAL REPORT, VARIAN'S MEDICAL ADVISOR WAS NOT ABLE TO RENDER A MEDICAL EVAL ON WHETHER THIS EVENT MAY HAVE CAUSED OR CONTRIBUTED TO A SERIOUS INJURY. SINCE VARIAN WAS NOT ABLE TO OBTAIN FURTHER DETAILS OF THE EVENT FROM THE CUSTOMER, IT WAS DETERMINED THAT AN MDR IS APPROPRIATE, AS THE INFO REASONABLY SUGGEST THAT THE DEVICE MAY HAVE CONTRIBUTED TO A SERIOUS INJURY. COMMON CLINICAL PRACTICE IS TO VERIFY THE LIGHT FIELD PROJECTION AGAINST PT'S MARKINGS (TATTOOS, SKIN MARKS, ETC); A MISMATCHED PT WOULD LIKELY NOT MATCH CORRECTLY OR VERIFY SOURCE-TO-SKIN-DISTANCE (SSD), WHICH WOULD LIKELY NOT MATCH FOR THE INCORRECT PT. STATE AND NATIONAL GUIDELINES TYPICALLY MANDATE THAT SITE HAVE A PROCEDURE FOR PT IDENTIFICATION ((B)(4) - FOR EXAMPLE). IN THE ABSENCE OF AN ELECTRONIC SYSTEM, A PAPER CHART WITH PT INFO WOULD BE USED. THE SAME CLINICAL PRACTICE GUIDELINE WOULD BE APPLIED FOR A PAPER CHART TO VERIFY PT IDENTITY. IN ADDITION, VARIAN'S LABELING PROVIDES A WARNING STATEMENT FOR PT ID: TREATING A PT WITH A PLAN THAT IS INCORRECT OR ASSIGNED TO ANOTHER PT MAY INJURE THE PT. IT IS THE RESPONSIBILITY OF THE OPERATOR TO ESTABLISH APPROPRIATE PROCEDURES TO VERIFY THE PT'S IDENTITY AND PLAN ASSIGNMENT POSITIVELY IDENTIFY THE CORRECT PT, AND VERIFY THAT THE CORRECT PLAN IS LOADED PRIOR TO TREATMENT. EXAMPLES OF POSITIVE IDENTIFICATION MAY INCLUDE, BUT ARE NOT LIMITED TO: PT PHOTOGRAPH, IDENTIFICATION NUMBER, OR PT NAME & DATE OF BIRTH. THE VARIAN 4DITC, OBI, AND ARIA PRODUCT INCLUDE VARIOUS TOOLS TO ASSIST WITH IDENTIFYING THE PT ASSIGNED TO A PLAN. NO ADD'L F/U TO THIS MDR IS EXPECTED.

    Description of Event or Problem · 1

    CUSTOMER CALLED IN ON (B)(6)2010, STATING THE WRONG PT PLAN WAS DELIVERED TO A PT SO, THEY HAD TO DELIVER TWO FRACTIONS TO THE PLAN IN ORDER TO ALSO TREAT THE CORRECT PT. CUSTOMER WOULD LIKE TO KNOW HOW TO CORRECT FOR THE EXTRA DOSE THAT WAS DELIVERED WITHIN THE PLAN AND ADD AN ADD'L FRACTION TO THE PLAN. VARIAN HELPDESK INSTRUCTED CUSTOMER TO ENTER A DOSE CORRECTION WITHIN RT CHART / HISTORY TAB TO REMOVE 180 CGY AND TO ENTER A NOTE EXPLAINING WHAT HAS OCCURRED. HELPDESK THEN EXPLAINED TO ADD THE ADD'L FRACTION CUSTOMER WILL NEED TO CREATE A PLAN REVISION AND ADD THE FRACTION ON THE REVISED PLAN. HELPDESK SUGGESTED CUSTOMER ALSO DOCUMENTED WHY THE PLAN REVISION WAS MADE AND THE EXTRA FRACTION WAS ENTERED FOR FUTURE REFERENCE. THE CUSTOMER DECLINED TO PROVIDED FURTHER INFO ABOUT THIS INCIDENT AND NO OTHER DETAILS WERE PROVIDED REGARDING THE PT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1