BEUDAMED
    FDA Adverse Event Other Summary report: N

    CLINAC

    MDR report key: 973524 · Received April 27, 2007

    Report

    Report Number
    2914292-2007-00022
    Event Type
    Other
    Date Received
    April 27, 2007
    Date of Event
    February 12, 2007
    Report Date
    February 12, 2007
    Manufacturer
    VARIAN MEDICAL SYSTEMS
    Product Code
    IYE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIST

    Narratives

    Additional Manufacturer Narrative · 1

    DURING PT SET-UP ONE OF THE THERAPISTS PICKED UP THE PENDANT AND HIT "ENTER" AND "AUTO" TO AUTOMATICALLY MOVE THE GANTRY TO THE CORRECT TREATMENT POSITION. IT IS UNK IF OTHER DRIVE COMMANDS WERE PERFORMED, WHETHER PURPOSEFULLY OR INADVERTENTLY. THE HISTORY IN RT CHART WAS ANALYZED BY A VARIAN EMPLOYEE AND THERE WERE NO MECHANICAL POSITIONS "ACQUIRED" THAT DAY OR THE PREVIOUS DAY. THE ONE FIELD WHERE THEY BELIEVE THE COUCH MAY HAVE MOVED SLIGHTLY DURING PT SET-UP IS THE ONLY FIELD THAT HAD A COUCH VERTICAL DIFFERENT FROM THE OTHER FIELDS. THE VARIAN SYSTEM CORRECTLY DISPLAYED THE COUCH POSITION AS DIFFERENT FROM THE PLANNED POSITION, IMPEDING TREATMENT, BUT THIS PARAMETER WAS OVER-RIDDEN BY THE USER AND TREATMENT WAS PERFORMED ANYWAY. THE CUSTOMER HAS BEEN CONTACTED NUMEROUS TIMES FOR MORE INFO IN ORDER FOR VARIAN TO PROPERLY PERFORM AN INVESTIGATION, BUT TO DATE THERE HAS BEEN NO REPLY. THERE WAS INSUFFICIENT INFO ON THE PT'S PLAN FOR THE VARIAN MEDICAL PROFESSIONAL ON STAFF TO MAKE AN INDEPENDENT ASSESSMENT ON THE EFFECT OF THE REPORTED VARIANCE FROM PRESCRIPTION. THEREFORE, VARIAN CAN NOT RULE OUT THE POSSIBILITY OF SERIOUS INJURY, THOUGH THE INITIAL REPORTER DID STATE THAT NO INJURY OCCURRED. VARIAN WILL SUBMIT A SUPPLEMENTAL REPORT SHOULD ADDITIONAL INFO BECOME AVAILABLE.

    Description of Event or Problem · 1

    AFTER SETTING UP A PT FOR AN INTENSITY MODULATED RADIOTHERAPY (IMRT) TREATMENT THE THERAPIST AT THE TREATMENT CONSOLE NOTICED THAT THE VERTICAL COUCH POSITIONED FOR THE PT'S LEFT ANTERIOR OBLIQUE (LAO) FIELD WAS 2.5CM OFF FROM ALL OTHER FIELDS. THE THERAPIST STATED THAT SHE "THOUGHT IT MIGHT BE A GLITCH IN THE PLAN", OVERRODE THE VERTICAL PARAMETER, AND PROCEEDED TO TREAT THE PT. SUBSEQUENT TO THIS TREATMENT THE THERAPIST FOUND THAT THE COUCH VERTICAL ACTUALLY WAS 2.5CM OFF IN THE ANTERIOR DIRECTION FOR THIS FIELD. THE RADIATION DOSE DELIVERED TO THE AFFECTED SITE WAS 118 MONITOR UNITS (MU) FOR A DOSE OF 45 CGY. THIS FIELD WAS ONE OF 4 FIELDS, WITH A PRECSCRIBED DAILY DOSE OF 180 CGY OF 5040 TOTAL CGY. PER ON-SITE PHYSICIST, NO CRITICAL STRUCTURES WERE AFFECTED. THE TUMOR RECEIVED MORE DOSE THAN THE ORIGINAL PRESCRIPTION (8.5% INCREASE IN MAX DOSE FOR 1 OF 28 FRACTIONS, 4.1% INCREASE IN THE MEAN DOSE FOR 1 FRACTION). THE PHYSICIST CONFIRMED THAT THERE WAS NO IMMEDIATE PT INJURY, AND THAT THE PLAN COULD BE COMPENSATED SUCH THAT THERE IS NO ADVERSE IMPACT TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CLINAC LINEAR ACCELERATOR IYE VARIAN MEDICAL SYSTEMS 23 EX *

    Patients

    Seq Age Sex Outcome Treatment
    1 *