BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROTEUSPLUS

    MDR report key: 16699421 · Received April 7, 2023

    Report

    Report Number
    3000256071-2023-00001
    Event Type
    Malfunction
    Date Received
    April 7, 2023
    Date of Event
    March 8, 2023
    Report Date
    April 30, 2024
    Manufacturer
    IBA (ION BEAM APPLICATIONS)
    Product Code
    LHN
    UDI-DI
    05404013801138
    PMA / PMN Number
    K163500
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    IBA REFERENCE: (B)(4) DESCRIPTION OF THE EVENT: ON (B)(6) 2023, AS PART OF A PREVENTIVE MAINTENANCE, IBA CARRIED OUT THE "REALISOOFFSET VALIDATION" PROCEDURE. THE MEASUREMENTS SHOWED A MAXIMUM ERROR IN POSITION OF THE PATIENT POSITIONING SYSTEM (PPS) IN GANTRY TREATMENT ROOM 3 OF 3,4 MM. HOWEVER, THIS PROCEDURE IS CARRIED OUT ON A SINGLE POINT OF THE TREATMENT VOLUME AND DOES NOT ENSURE THAT THERE ARE NO HIGHER ERRORS ON OTHER POINTS OF THE TREATMENT VOLUME. THEREFORE, IBA IS REPORTING THIS EVENT PREVENTIVELY. IMPACT OF THE EVENT: AN ERROR IN POSITION AT THE PPS LEVEL WILL BE IDENTIFIED IF THE USER ACQUIRES X-RAY IMAGES AFTER APPLYING THE CORRECTION VECTOR AS RECOMMENDED IN THE PROTEUS 235 - CLINICAL USER GUIDE. THIS MITIGATION CANNOT BE CONSIDERED AS EFFECTIVE IN ALL CASES AS, DEPENDING ON THE TREATMENT PLAN, MECHANICAL INTERFERENCES BETWEEN THE PPS AND THE FLAT PANELS MAY PREVENT THE ACQUISITION OF X-RAY IMAGES FOR SOME POSITIONS OF THE TREATMENT VOLUME. IBA CONSIDERS THAT THERE IS A RISK OF A NON-DETECTED ERROR IN POSITION UP TO 5 MM FOR POSITIONS WHERE IMAGING THE PATIENT WITH X-RAY IS NOT POSSIBLE BECAUSE OF THESE MECHANICAL INTERFERENCES. THE ERROR WOULD VARY CONTINUOUSLY OVER THE TREATMENT VOLUME. IBA CONSIDERS THAT THERE ARE CHANCES THAT, BY ACQUIRING X-RAY IMAGES ON OTHER POINTS OF THE TREATMENT VOLUME, THE USER WOULD BE ABLE TO DETECT INTERMEDIATE ERRORS BETWEEN 0 AND 5 MM. BASED ON THIS INFORMATION, IBA EVALUATES THE RISK OF MAJOR INJURY AS POSSIBLE. UPDATES ON MAY 26 , 2023: ON (B)(6) 2023, THE "REALISOOFFSET" PARAMETER WAS READJUSTED BY THE IBA TEAM ON SITE BASED ON THE FAILING POINT OF VOLUME TESTED TO MEET THE IBA TOLERANCE OF 1MM. HOWEVER, AS THE "REALISOOFFSET VALIDATION" PROCEDURE IS PLAYED ON A SINGLE POINT OF THE TREATMENT VOLUME, THE READJUSTMENT OF THE PARAMETER DOES NOT ENSURE THAT THERE ARE NO HIGHER ERRORS ON OTHER POINTS OF THE TREATMENT VOLUME THAT WILL NOT BE CORRECTED BY THIS READJUSTMENT. IBA IS CONDUCTING AN ANALYSIS OF THE PPS ACCURACY BASED ON THE MEASUREMENTS DONE BY THE PPS SUB-CONTRACTOR AFTER A FAILED "REALISOOFFSET VALIDATION" BY THE IBA SITE TEAM. BASED ON THE RESULTS OF THIS ANALYSIS, THE SAFETY RISK WILL BE REEVALUATED.

    Description of Event or Problem · 0

    IBA REFERENCE: NCIPT-10233 DESCRIPTION OF THE EVENT: ON (B)(6) 2023, AS PART OF A PREVENTIVE MAINTENANCE, IBA CARRIED OUT THE "REALISOOFFSET VALIDATION" PROCEDURE. THE MEASUREMENTS SHOWED A MAXIMUM ERROR IN POSITION OF THE PATIENT POSITIONING SYSTEM (PPS) IN GANTRY TREATMENT ROOM 3 OF 3,4 MM. HOWEVER, THIS PROCEDURE IS CARRIED OUT ON A SINGLE POINT OF THE TREATMENT VOLUME AND DOES NOT ENSURE THAT THERE ARE NO HIGHER ERRORS ON OTHER POINTS OF THE TREATMENT VOLUME. THEREFORE, IBA IS REPORTING THIS EVENT PREVENTIVELY. IMPACT OF THE EVENT: AN ERROR IN POSITION AT THE PPS LEVEL WILL BE IDENTIFIED IF THE USER ACQUIRES X-RAY IMAGES AFTER APPLYING THE CORRECTION VECTOR AS RECOMMENDED IN THE PROTEUS 235 - CLINICAL USER GUIDE. THIS MITIGATION CANNOT BE CONSIDERED AS EFFECTIVE IN ALL CASES AS, DEPENDING ON THE TREATMENT PLAN, MECHANICAL INTERFERENCES BETWEEN THE PPS AND THE FLAT PANELS MAY PREVENT THE ACQUISITION OF X-RAY IMAGES FOR SOME POSITIONS OF THE TREATMENT VOLUME. IBA CONSIDERS THAT THERE IS A RISK OF A NON-DETECTED ERROR IN POSITION UP TO 5 MM FOR POSITIONS WHERE IMAGING THE PATIENT WITH X-RAY IS NOT POSSIBLE BECAUSE OF THESE MECHANICAL INTERFERENCES. THE ERROR WOULD VARY CONTINUOUSLY OVER THE TREATMENT VOLUME. IBA CONSIDERS THAT THERE ARE CHANCES THAT, BY ACQUIRING X-RAY IMAGES ON OTHER POINTS OF THE TREATMENT VOLUME, THE USER WOULD BE ABLE TO DETECT INTERMEDIATE ERRORS BETWEEN 0 AND 5 MM. BASED ON THIS INFORMATION, IBA EVALUATES THE RISK OF MAJOR INJURY AS POSSIBLE.

    Description of Event or Problem · 0

    IBA REFERENCE: (B)(4). DESCRIPTION OF THE EVENT: ON MARCH 08, 2023, AS PART OF A PREVENTIVE MAINTENANCE, IBA CARRIED OUT THE "REALISOOFFSET VALIDATION" PROCEDURE. THE MEASUREMENTS SHOWED A MAXIMUM ERROR IN POSITION OF THE PATIENT POSITIONING SYSTEM (PPS) IN GANTRY TREATMENT ROOM 3 OF 3.4 MM. HOWEVER, THIS PROCEDURE IS CARRIED OUT ON A SINGLE POINT OF THE TREATMENT VOLUME AND DOES NOT ENSURE THAT THERE ARE NO HIGHER ERRORS ON OTHER POINTS OF THE TREATMENT VOLUME. THEREFORE, IBA IS REPORTING THIS EVENT PREVENTIVELY. IMPACT OF THE EVENT: AN ERROR IN POSITION AT THE PPS LEVEL WILL BE IDENTIFIED IF THE USER ACQUIRES X-RAY IMAGES AFTER APPLYING THE CORRECTION VECTOR AS RECOMMENDED IN THE PROTEUS 235 - CLINICAL USER GUIDE. THIS MITIGATION CANNOT BE CONSIDERED AS EFFECTIVE IN ALL CASES AS, DEPENDING ON THE TREATMENT PLAN, MECHANICAL INTERFERERENCES BETWEEN THE PPS AND THE FLAT PANELS MAY PREVENT THE ACQUISITION OF X-RAY IMAGES FOR SOME POSITIONS OF THE TREATMENT VOLUME. IBA CONSIDERS THAT THERE IS A RISK OF NON-DETECTED ERROR IN POSITION UP TO 5 MM FOR POSITIONS WHERE IMAGING THE PATIENT WITH X-RAY IS NOT POSSIBLE BECAUSE OF THESE MECHANICAL INTERFERENCES. THE ERROR WOULD VARY CONTINUOUSLY OVER THE TREATMENT VOLUME. IBA CONSIDERS THAT THERE ARE CHANCES THAT, BY ACQUIRING X-RAY IMAGES ON OTHER POINTS OF THE TREATMENT VOLUME, THE USER WOULD BE ABLE TO DETECT INTERMEDIATE ERRORS BETWEEN 0 AND 5 MM. BASED ON THIS INFORMATION, IBA EVALUATES THE RISK OF MAJOR INJURY AS POSSIBLE. UPDATES ON MAY 26, 2023: ON MARCH 10, 2023, THE "REALISOOFFSET VALIDATION" PARAMETER WAS READJUSTED BY THE IBA TEAM ON SITE BASED ON THE FAILING POINT OF VOLUME TESTED TO MEET THE IBA TOLERANCE OF 1 MM. HOWEVER, AS THE "REALISOOFFSET VALUDATION" PROCEDURE IS PLAYED ON A SINGLE POINT OF THE TREATMENT VOLUME, THE READJUSTMENT OF THE PARAMETER DOES NOT ENSURE THAT THERE ARE NO HIGHER ERRORS ON OTHER POINTS OF THE TREATMENT VOLUME THAT WILL NOT BE CORRECTED BY THIS READJUSTMENT. IBA IS CONDUCTING AN ANALYSIS OF THE PPS ACCURACY BASED ON THE MEASUREMENTS DONE BY THE PPS SUB-CONTRACTOR AFTER A FAILED "REALISOOFFSET VALIDATION" PROCEDURE BY THE IBA SITE TEAM. BASED ON THE RESULTS OF THIS ANALYSIS, THE SAFETY RISK WILL BE REEVALUATED. UPDATES ON APRIL 30, 2024: SINCE THE LAST UPDATE, IBA TECHNICAL EXPERTS AND IBA TEAM ON SITE HAVE PERFORMED INVESTIGATIONS ON THE POSITIONING MANAGEMENT SYSTEM (PMS) AND ON THE PATIENT POSITIONING AND VERICATION SYSTEM (PPVS) IN COLLABORATION WITH THE CUSTOMER TEAM AND BIZLINK, THE MANUFACTURER OF THE ORION PPS. SEVERAL MISSIONS WERE ORGANIZED ON SITE TO INVESTIGATE THE ISSUE IN ACCURACY: - MISSION OF BIZLINK IN SEPTEMBER 2023, - MISSION OF IBA EXPERTS IN OCTOBER 2023, - MISSION OF BIZLINK AND IBA EXPERTS IN DECEMBER 2023, - MISSION OF IBA EXPERTS IN JANUARY 2024. AS PREVENTIVE ACTIONS, STARTING JUNE 2023, IBA SITE TEAM HAS MONITORED THE RESULTS OF "REALISOOFFSET VALIDATION" PROCEDURE ON A DAILY BASIS AND READJUSTED THE "REALISOOFFSET" PARAMETER TO MEET THE IBA TOLERANCE OF 1 MM WHEN THE RESULTS WERE FAILING. FURTHERMORE, AS PREVENTIVE ACTIONS, STARTING NOVEMBER 2023, IBA RECOMMENDED THE USER TO: - TAKE A NEW SET OF X-RAY IMAGES TO VERIFY THE PROPER POSITIONING OF THE PATIENT, AFTER APPLYING AND IMPLEMENTING THE CORRECTIONS CALCULATED BY THE PPVS, - TREAT PATIENTS ONLY AT ANGLES WHERE THE X-RAY IMAGE ACQUISITON IS POSSIBLE (POSITIONS WHERE THERE IS NO MECHANICAL INTERFERENCE BETWEEN THE PPS AND THE FLAT PANELS). IBA IS NOT AWARE OF ANY SERIOUS INJURY RELATED TO THIS ISSUE. DURING THEIR MISSION IN DECEMBER 2023, BIZLINK REPLACED/MODIFIED SEVERAL ELEMENTS OF THE ORION PPS IN GANTRY TREATMENT ROOM 3: - THE A1 AND A2 GEARBOXES WERE REPLACED. - THE LOADCELL WAS REPLACED. - THE PATIENT POSITIONING SYSTEM CONTROL UNIT WAS SWAPPED WITH GANTRY TREATMENT ROOM 1. THE GANTRY TREATMENT ROOM 1 IS NOT USED FOR CLINICAL ACTIVITIES. - THE PPS WAS RECALIBRATED TO MEET THE BIZLINK ACCURACY TOLERANCE. SINCE THESE MODIFICATIONS, THE CHECKS PERFORMED BY THE IBA SITE TEAM HAVE CONFIRMED THAT THE RESULTS OF THE "REALISOOFFSET VALIDATION" PROCEDURE ARE STABLE IN TREATMENT ROOM 3, WITHIN THE IBA TOLERANCE OF 1 MM. THEREFORE, IBA CONSIDERS THAT THE RECURRENT PPS ACCURACY ISSUE IN THE TREATMENT ROOM 3 IS RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    441168 PROTEUSPLUS PROTON THERAPY SYSTEM LHN IBA (ION BEAM APPLICATIONS) PROTEUS 235 05404013801138

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other