BEUDAMED
    FDA Adverse Event Other Summary report: N

    CLINAC

    MDR report key: 2217306 · Received July 13, 2011

    Report

    Report Number
    2916710-2011-00082
    Event Type
    Other
    Date Received
    July 13, 2011
    Date of Event
    June 22, 2011
    Report Date
    June 22, 2011
    Manufacturer
    VARIAN MEDICAL SYSTEMS, INC.
    Product Code
    IYE
    PMA / PMN Number
    K100890
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    PRIOR TO THIS INCIDENT, THE SITE TRIED USING LASER GUARD A LONG TIME AGO (NO EXACT OR APPROXIMATE DATE), BUT FOUND IT WAS SLOWING THEM DOWN SO THEY DISABLED IT. THE CUSTOMER DID NOT CONTACT VARIAN TO REPORT THIS INCIDENT, ONLY AN E-MAIL TO THE FSR TO ASSIST THEM IN ENABLING LASER GUARD. ONCE THE LASER GUARD WAS ENABLED, MOTION TESTS WERE PERFORMED TO MAKE SURE THAT THE MOTION STOPS IF AN OBJECT GOES INTO THE SAFETY ZONE. THE RESULTS OF THE TESTS PROVED THAT THE LASER GUARD SYSTEM WAS IN A FULLY FUNCTIONAL STATE, HOWEVER IT WAS DISABLED AT THE TIME OF THE INCIDENT. THE CUSTOMER REFUSED TO PROVIDE ANY INFO ABOUT THIS INCIDENT OR THE PTS CONDITION, AND STATED THAT ONCE A COPY OF THE INCIDENT REPORT IS AVAILABLE FROM THEIR RISK GROUP WE WOULD BE ABLE TO OBTAIN A COPY. THIS EVENT APPEARS TO BE A USER ERROR, AS THE THERAPIST PRESSED THE WRONG DIRECTIONAL KEYS CAUSING THE GANTRY TO MOVE IN THE WRONG DIRECTION, STRIKING THE PT. THERE IS NO ALLEGATION OF A MACHINE MALFUNCTION AND THE THERAPIST IS CLEARLY AWARE OF THE ERROR. VARIAN HAS DISTRIBUTED A PRECAUTIONARY NOTICE (PNL) TO ALL APPLICABLE CUSTOMERS REGARDING THE POTENTIAL FOR GANTRY COLLISIONS DURING REMOTE AUTO MOTION. VARIAN HAS INITIATED A CAPA TO FURTHER ADDRESS GANTRY COLLISIONS AND FURTHER ACTIONS WILL BE ADDRESSED IN VARIAN'S CAPA PROCESS. ALL CORRECTIVE ACTION REGARDING THIS ISSUE WILL BE REPORTED UNDER THE GUIDELINES OF 21 CFR PART 806. NO ADDITIONAL F/U TO THIS MDR IS EXPECTED.

    Description of Event or Problem · 1

    A VARIAN FIELD SERVICE REP (FSR) RECEIVED AN EMAIL FROM A PHYSICIST AT (B)(6) MED CTR STATING: "WE WANT TO MAKE THE LASER GUARD ENABLED. COULD YOU SHOW UP TOMORROW MORNING? THIS NEEDS TO BE DONE ASAP". THE FSR SHOWED UP ON SITE AT 8:20 AM ON (B)(4) 2011, AND WAITED FOR THE PHYSICIST TO GET TO SITE. WHILE THE FSR WAITED AT SITE, HE HEARD CONVERSATIONS BETWEEN THE THERAPISTS AND THE NURSING STAFF ABOUT WHAT HAD HAPPENED THE DAY PRIOR. FROM THE CONVERSATIONS THAT THE FSR HEARD, THE FOLLOWING IS THE FSR'S UNDERSTANDING OF THE INCIDENT: A PT WAS TREATED, THE LAST FIELD WAS A COUCH KICK FIELD. AFTER THE FIELD WAS TREATED THE THERAPIST WAS ROTATING THE GANTRY VIA MANUAL MOTION FROM OUTSIDE THE ROOM, WHILE OTHER THERAPISTS WERE GOING TO THE ROOM TO TAKE THE PT DOWN. THE THERAPIST CONSOLE PRESSED THE WRONG DIRECTION KEYS, THE GANTRY PINNED THE PT BETWEEN THE COUCH AND THE GANTRY, PT SCREAMED, EMS WERE CALLED TO THE SITE AND THE PT WAS TAKEN TO THE ER. PT IS FINE, ACCORDING TO THE NURSING STAFF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CLINAC ACCELERATOR, LINEAR, MEDICAL IYE VARIAN MEDICAL SYSTEMS, INC. H14

    Patients

    Seq Age Sex Outcome Treatment
    1