BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLINAC

    MDR report key: 2240900 · Received August 8, 2011

    Report

    Report Number
    2916710-2011-00105
    Event Type
    Malfunction
    Date Received
    August 8, 2011
    Date of Event
    July 11, 2011
    Report Date
    July 11, 2011
    Manufacturer
    VARIAN MEDICAL SYSTEMS, INC.
    Product Code
    IYE
    PMA / PMN Number
    K100890
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THOUGH STILL UNDER INVESTIGATION, VARIAN HAS DETERMINED THAT A MDR IS APPROPRIATE AS THIS POSSIBLE MALFUNCTION, SHOULD IT RECUR, COULD POTENTIALLY CAUSE SERIOUS INJURY. ADD'L FOLLOW-UP TO THIS MDR IS EXPECTED UPON COMPLETION OF THE INVESTIGATION. THE PHYSICIST REPORTED THAT THE PT WAS BEING TREATED FOR TRIGEMINAL NEURALGIA WITH 6-MV PHOTON IRRADIATION USING A STEREOTACTIC CONICAL COLLIMATOR ACCESSORY WITH A 5-MM OPENING. THE PLANNED DELIVERED DOSE WAS 90 GY IN ONE FRACTION. SEVEN ARC FIELDS WERE PLANNED, WITH EACH ARC BEING DELIVERED IN TWO OR MORE PASSES. THE PLANNED FIELD SIZE WAS 5CM X 5CM AND THE STAFF HAD CONFIRMED THAT THIS FIELD SIZE WAS ENTERED CORRECTLY AT THE START OF THE FIRST TREATMENT. ALSO, BEFORE TREATMENT, THE STAFF HAD DISENGAGED THE RECORD-AND-VERIFY SOFTWARE AND THE TREATMENT DELIVERY MANAGEMENT SOFTWARE, AND THESE FEATURES REMAINED DISENGAGED DURING THE ENTIRE DELIVERY OF THE TREATMENT. THE PHYSICIST REPORTED THAT DURING A PLANNED MANUAL ADJUSTMENT OF THE TREATMENT COUCH POSITION BETWEEN THE FIFTH AND SIXTH ARC, THE STAFF NOTICED THAT THE FIELD SIZE DEFINED BY THE COLLIMATING JAWS WAS 9.2CM X 10.7CM, INSTEAD OF THE PLANNED 5CM X 5CM. THE STAFF IMMEDIATELY RESET THE FIELD SIZE TO THE 5CM X 5CM PLANNED VALUES, AND DELIVERED THE REMAINING SIXTH AND SEVENTH ARCS AS ORIGINALLY PLANNED. IF ANY RADIATION HAS BEEN DELIVERED USING THE NOTICED LARGER FIELD SIZE SETTINGS, THEN SOME RADIATION WOULD NOT HAVE BEEN FULLY SHIELDED AND THE PT WOULD HAVE RECEIVED UNINTENDED DOSE. IF THE STAFF HAD NOTICED THE LARGER FIELD SIZE PRIOR TO ANY RADIATION BEING DELIVERED, THEN ALL OF THE RADIATION WOULD HAVE BEEN FULLY SHIELDED AND THE PT WOULD HAVE RECEIVED NO UNINTENDED DOSE. SINCE THE STAFF HAD DISENGAGED THE TREATMENT DELIVERY MANAGEMENT SOFTWARE AND THE RECORD-AND-VERIFY SOFTWARE PRIOR TO AND DURING THE DELIVERY OF THE TREATMENT, THERE ARE NO ELECTRONIC RECORDS TO DETERMINE AT WHICH POINT DURING THE TREATMENT PROCESS THE FIELD SIZE HAD CHANGED. THEREFORE, IT CANNOT BE DETERMINED WHAT TOTAL DOSE IF ANY, MIGHT HAVE BEEN DELIVERED OUTSIDE OF THE PLANNED VOLUME. IF THE WRONG FIELD SIZE SETTINGS WERE PRESENT DURING ONE OR MORE OF THE PREVIOUS ARCS (WHICH CANNOT BE DETERMINED), THEN THERE IS A POSSIBILITY THAT A HIGH UNINTENDED DOSE MAY HAVE BEEN DELIVERED TO A SIGNIFICANT PORTION OF THE PT'S BRAIN. THE PHYSICIST ON-SITE REPORTED THAT, UPON EXAMINATION AND EVAL OF THE PT BY THE ATTENDING PHYSICIAN(S) AFTER THE TREATMENT, NO ACUTE RADIATION EFFECTS WERE APPARENT, LEADING THEM TO THE CONCLUSION THAT THERE WAS NO PT INJURY. HOWEVER, SINCE THE POSSIBILITY OF A HIGH DOSE HAVING BEEN DELIVERED TO A LARGE VOLUME CANNOT BE RULED OUT, THERE MAY BE A POSSIBILITY OF SERIOUS LATE EFFECTS IN PORTIONS OF THE BRAIN AND SURROUNDING ORGANS. THE MFR PERFORMED A COMPLETE SYSTEM PERFORMANCE AUDIT ON THE LINEAR ACCELERATOR USED FOR THE TREATMENT OVER A PERIOD OF DAYS JUST AFTER THE INCIDENT WAS REPORTED. THE TESTS FOUND THAT THE ACCELERATOR MET ITS DESIGN SPECIFICATIONS IN ALL AREAS AND FOUND NO ISSUES RELEVANT TO THE REPORTED INCIDENT. INVESTIGATION OF THE INCIDENT IS ONGOING, AND ANY NEW INFO WILL BE REPORTED IN A TIMELY MANNER.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THEY HAD A POTENTIAL MISTREATMENT; THE CUSTOMER STATED THAT THEY WERE TREATING A STEREO TACTIC ARC BRAIN WITH A 5 BY 5 CONE. HE STATE AT ABOUT ARC NUMBER 20 THAT THE PHYSICISTS NOTICED THAT THE FIELD SIZE HAD CHANGED FROM A 5 BY 5 TO A 9.2 BY 10.7; THEY NOTICED THIS BETWEEN FIELDS SO THEY DON'T KNOW WHEN THE FIELD SIZE CHANGED. THE CUSTOMER WOULD LIKE FOR THIS TO BE INVESTIGATED AS SOON AS POSSIBLE SO THAT THEIR PATIENT CAN CONTINUE TO BE TREATED. THE CUSTOMER ALSO REPORTED THAT THEY ARE NOT SURE THAT THEY MISTREATED. HE STATES THAT THEY WERE TREATING OUTSIDE OF MOSAIC AND THIS COULD HAVE CHANGED BETWEEN FIELDS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CLINAC ACCELERATOR, LINEAR, MEDICAL IYE VARIAN MEDICAL SYSTEMS, INC. H29

    Patients

    Seq Age Sex Outcome Treatment
    1 Other