BEUDAMED
    FDA Adverse Event Death Summary report: N

    PROTEUSPLUS

    MDR report key: 10875047 · Received November 20, 2020

    Report

    Report Number
    3000256071-2020-00004
    Event Type
    Death
    Date Received
    November 20, 2020
    Date of Event
    May 17, 2018
    Report Date
    November 6, 2020
    Manufacturer
    IBA (ION BEAM APPLICATIONS)
    Product Code
    LHN
    UDI-DI
    05404013810604
    PMA / PMN Number
    K082416
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION H3: EVALUATION SUMMARY IS PROVIDED IN SECTION B5 (DESCRIBE EVENT OR PROBLEM).

    Description of Event or Problem · 0

    ON NOVEMBER 6, 2020, IBA WAS MADE AWARE OF A DELAYED SERIOUS INJURY FOLLOWING A PROTON THERAPY TREATMENT RECEIVED IN THE SECOND QUARTER OF 2018. INITIAL REPORT WAS SUBMITTED ON NOVEMBER 20, 2020. ON JANUARY 12, 2021, IBA WAS INFORMED THAT THE PATIENT DIED ON (B)(6) 2021. IBA HAS LIMITED INFORMATION REGARDING THE PATIENT'S DEATH AND CANNOT DETERMINE WHETHER THE DEATH IS RELATED TO THE REPORTED EVENT. HOWEVER, WE ARE REPORTING THE DEATH IN A SUPPLEMENTAL REPORT AS A CONSERVATIVE MEASURE TO ENSURE COMPREHENSIVE REPORTING. EVALUATION SUMMARY: EXTENSIVE ANALYSIS OF LOGS PRODUCED BY THE SYSTEM AND TESTS TO REPRODUCE THE SITUATION INDICATED THAT AN UNINTENDED BEAM DELIVERY OCCURRED ON (B)(6) 2018, DUE TO AN UNLIKELY COMBINATION OF EVENTS THAT RESULTED IN AN UNINTENDED DOSE OF RADIATION PRIOR TO DELIVERY OF THE THERAPEUTIC DOSE. AT APPROXIMATELY THE SAME TIME THAT THE THERAPIST REQUESTED THE ROOM PREPARATION, THE MAIN CONTROL ROOM (MCR) OPERATOR SWITCHED THE CONTROL SYSTEM TO A TROUBLESHOOTING SCREEN TO RESOLVE A DIFFICULTY WITH THE ION SOURCE OF THE CYCLOTRON. THIS RESULTED IN A BEAM BEING GENERATED BASED ON 50% DUTY CYCLE INTERNAL PULSES, INSTEAD OF BEING EXTERNALLY CONTROLLED BY THE TREATMENT ROOM EQUIPMENT. WHEN THE TREATMENT WAS STARTED ACCORDING TO THE REQUEST FROM THE THERAPIST, THE BEAM STOP RETRACTED, RESULTING IN DELIVERY TO THE PATIENT OF THE BEAM THAT WAS GENERATED BY THE MCR TROUBLESHOOTING ACTIVITIES. THIS ABNORMAL BEAM WAS IMMEDIATELY DETECTED BY THE SCANNING CONTROLLER (THAT HAD NOT STARTED SCANNING THE BEAM YET) AND THE ABNORMAL BEAM WAS STOPPED. A SECOND BEAM REQUEST WAS THEN PERFORMED BY THE THERAPIST AND THIS RESTARTED THE UNSCANNED BEAM. DURING INSTALLATION OF THE THERAPY SAFETY SYSTEM INTERLOCK OF THE SCANNING CONTROLLER AT THE TIME OF THE INSTALLATION OF THE PENCIL BEAM SCANNING TREATMENT MODE ON (B)(6) 2017, THE FACTORY BYPASSES NEEDED FOR TESTING WERE NOT REMOVED. THIS RESULTED IN THE THERAPY SAFETY SYSTEM INTERLOCK OF THE SCANNING CONTROLLER NOT FUNCTIONING, ALLOWING THE UNSCANNED BEAM TO OCCUR FOR SEVERAL SECONDS AND RESULTING IN AN UNINTENDED DOSE BEING DELIVERED TO THE PATIENT. IF THE BYPASSES HAD BEEN REMOVED, THE UNINTENDED AND UNSCANNED BEAM GENERATED BY THE MCR TROUBLESHOOTING ACTIVITIES WOULD HAVE BEEN STOPPED IMMEDIATELY, AND IT WOULD NOT HAVE BEEN DELIVERED TO THE PATIENT. AS DESCRIBED BELOW, THIS EVENT CAN NO LONGER HAPPEN DUE TO INSTALLATION OF A NEW BEAM ABSENCE ELECTRONIC UNIT, WHICH OCCURRED PRIOR TO LEARNING OF THIS EVENT. NONETHELESS, THE FACTORY BYPASSES ON THE SCANNING CONTROLLER IN THE OCCURRENCE SITE HAVE BEEN REMOVED. AS NOTED ABOVE, THIS EVENT CAN NO LONGER HAPPEN EVEN IF THE BYPASSES WERE LEFT IN PLACE. ON (B)(6) 2020, PRIOR TO LEARNING OF THIS EVENT, A NEW BEAM ABSENCE ELECTRONIC UNIT WAS INSTALLED, AND SUCH UNIT PREVENTS THE RETRACTION OF THE BEAM STOPS IF ANY BEAM IS PRESENT AT THE CYCLOTRON EXIT BEFORE THE MECHANICAL BEAM STOPS ARE RETRACTED, EVEN IF A FACTORY BYPASS IS LEFT IN THE SCANNING CONTROLLER DURING INSTALLATION. THUS, IF A TREATMENT REQUEST IS MADE WHILE A BEAM IS PRESENT AT THE CYCLOTRON EXIT, THE NEW BEAM ABSENCE ELECTRONIC UNIT WILL PREVENT THE BEAM STOPS FROM RETRACTING, AND NO BEAM CAN BE DELIVERED. THIS NEW BEAM ABSENCE ELECTRONIC UNIT WAS DELIVERED ON ALL PROTON THERAPY SITES EQUIPPED WITH THE SAME SCANNING CONTROLLER. NONETHELESS, IBA ASKED ITS PERSONNEL ON SITE TO PERFORM A ROUTINE INSPECTION OF THE SCANNING CONTROLLERS ON THEIR RESPECTIVE SYSTEMS TO IDENTIFY WHETHER THE FACTORY BYPASSES HAD BEEN LEFT IN PLACE, WITH THE INTENTION THAT IF A FACTORY BYPASS HAD BEEN FOUND, IBA COULD EVALUATE THE LOGS TO IDENTIFY WHETHER ANY OTHER PATIENTS COULD HAVE BEEN EXPOSED TO UNINTENDED IRRADIATION DUE TO FAILURE OF THE SCANNING CONTROLLER INTERLOCK PRIOR TO INSTALLATION OF THE NEW BEAM ABSENCE ELECTRONIC UNIT. THIS INSPECTION CONFIRMED THAT THE SITUATION IN THE OCCURRENCE SITE WAS UNIQUE, DUE TO A HUMAN ERROR AT THE INSTALLATION OF THE SCANNING CONTROLLER, AND THAT THE FACTORY BYPASSES HAD BEEN REMOVED FROM ALL OTHER SYSTEMS. THUS, IT WAS NOT POSSIBLE THAT THIS EVENT HAD OCCURRED WITH ANY OTHER SYSTEMS.

    Description of Event or Problem · 1

    ON NOVEMBER 6, 2020, IBA WAS MADE AWARE OF A DELAYED SERIOUS INJURY FOLLOWING A PROTON THERAPY TREATMENT RECEIVED IN THE SECOND QUARTER OF 2018. IBA'S INVESTIGATION IS ONGOING. A SUPPLEMENTAL REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION HAS BEEN COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1344006 PROTEUSPLUS PROTON THERAPY SYSTEM LHN IBA (ION BEAM APPLICATIONS) PROTEUS 235 05404013810604

    Patients

    Seq Age Sex Outcome Treatment
    1 Death| O