BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRILOGY TX DELIVERY SYSTEM (NOVALIS TX)

    MDR report key: 2218218 · Received August 11, 2011

    Report

    Report Number
    2916710-2011-00106
    Event Type
    Malfunction
    Date Received
    August 11, 2011
    Date of Event
    July 13, 2011
    Report Date
    July 13, 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
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY: A COLLISION OCCURRED BETWEEN THE GANTRY AND THE ROBOTICS COUCH TOP (BRAINLAB 6 DEGREES OF FREEDOM COUCH TOP). HAD THE COLLISION CAUSED A CHANGE IN ANY COUCH AXIS (LATERAL, LONGITUDINAL, HEIGHT AND ROTATION) MONITORED BY THE CLINAC'S CONTROL SYSTEM DURING BEAM-ON, THE CLINAC'S CONTROL SYSTEM WOULD IMMEDIATELY HAVE ASSERTED A MOTION INTERLOCK. THE CLINAC LOG FOR THAT DATE DOES NOT SHOW ANY MOTION INTERLOCKS THAT DAY. IF ANY OF THE COUCH'S AXIS MOVED MORE THAN 2 MM (COUCH ROTATION .25 DEGREES) A MOTION INTERLOCK WOULD HAVE BEEN GENERATED. SUBSEQUENT TESTING BY THE LOCAL SERVICE VERIFIED THIS WAS THE CASE, AND ANY MOTION EXCEEDING 2 MM OR (COUCH ROTATION OF .25 DEGREES) ACTIVATES THE MOTION INTERLOCK ON THIS MACHINE. LIKELY ROOT CAUSE: THIRD PARTY EQUIPMENT INTERFACE COMMUNICATION ISSUE (BRAINLAB 6 DEGREES OF FREEDOM COUCH TOP). NO VARIAN CORRECTIVE ACTION IS RECOMMENDED AT THIS TIME, HOWEVER THIS COMPLAINT HAS BEEN ESCALATED TO BRAINLAB (3RD PARTY MANUFACTURER). (B)(4). VARIAN WILL BE IN COMMUNICATION WITH BRAIN LAB'S ENGINEERING DEPARTMENT REGARDING THIS EVENT. A VARIAN MEDICAL ADVISER HAS REVIEWED THE REPORTED MISTREATMENT AND HAS DETERMINED THAT THE INFORMATION PROVIDED DOES NOT REASONABLY SUGGEST THAT THE VARIAN DEVICE IN QUESTION HAS OR MAY HAVE CAUSED OR CONTRIBUTED TO A DEATH OR SERIOUS INJURY. NO FOLLOW-UP TO THIS MDR IS EXPECTED.

    Description of Event or Problem · 1

    UNEXPECTED COUCH MOVEMENT WHILE BEAMING ON FOR FIRST TREATMENT FIELD (NAMES ARC 2- PLANNED GANTRY: 200 TO 310, COLL: 320, MU: 634, COUCH ANGLE: 0). THE PATIENT WAS SET UP FOR SECOND TREATMENT FRACTION AND IMAGED WITH EXACTRAC IMAGING SOFTWARE. INITIAL COUCH CORRECTIONS WERE MADE, AND VERIFICATION IMAGES RETAKEN, WHICH WERE WITHIN DEPARTMENTAL EXTRA-CRANIAL TOLERANCE OF 2 MM AND 2 DEGREES. BEAM WAS TURNED ON FOR ARC 2. WHILE ARC WAS BEING DELIVERED, A SNAP VERIFICATION WAS TAKEN, WHICH WAS OUT OF TOLERANCE. BEAM WAS TURNED OFF WITH GANTRY AT 269 DEGREES AFTER DELIVERING 259 MU. AFTER PERFORMING EXACTRAC IMAGES AGAIN, ARC 2 WAS THEN RESTARTED, AND SNAP VERIFICATION ONCE AGAIN WAS TAKEN WHICH WAS OUT OF TOLERANCE. 18 MU WERE DELIVERED BEFORE BEAMING OFF. WHEN FULL EXACTRAC IMAGING PERFORMED, IMAGES WERE ONCE AGAIN 14 MM OUT. CORRECTION WAS MADE AND REIMAGED. DUE TO CONSISTENT MOVEMENT AND NO OBVIOUS PATIENT MOVEMENT, THE SCENARIO WAS RECREATED, WITHOUT BEAMING ON, BY MOVING GANTRY FROM 180 TO 230; COUCH MOVEMENT WAS THEN OBSERVED ON EXACTRAC LONG VALUES, CONSOLE LONG VALUES AND ON CAMERA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRILOGY TX DELIVERY SYSTEM (NOVALIS TX) ACCELERATOR, LINEAR, MEDICAL IYE VARIAN MEDICAL SYSTEMS, INC. H14

    Patients

    Seq Age Sex Outcome Treatment
    1 Other