PROTEUSPLUS
Report
- Report Number
- 3000256071-2023-00003
- Event Type
- Malfunction
- Date Received
- May 26, 2023
- Date of Event
- April 27, 2023
- Report Date
- October 30, 2023
- Manufacturer
- IBA (ION BEAM APPLICATIONS)
- Product Code
- LHN
- PMA / PMN Number
- K163500
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PL
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
IBA REFERENCE: NCIPT-11871 DESCRIPTION OF THE EVENT: ON (B)(6) 2023, IBA WAS INFORMED THAT THE ISOCENTRICITY TEST PERFORMED BY THE CUSTOMER FAILED FOR THE PATIENT POSITIONING SYSTEM (PPS) IN GANTRY TREATMENT ROOM 4. IBA TIGHTENED THE SCREWS OF THE AXES 3 AND 4 OF THE PPS TO CORRECT A SLIPPAGE VISIBLE ON THESE AXES. THEN, IBA CARRIED OUT THE "REALISOOFFSET VALIDATION" PROCEDURE TO VERIFY THE PPS ACCURACY. THE MEASUREMENTS WERE WITHIN THE IBA TOLERANCE OF 1MM. 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. ON (B)(6) 2023, IBA WAS INFORMED THAT THE ERROR INITIALLY MEASURED BY THE CUSTOMER DURING THE ISOCENTRICITY TEST WAS 7,8MM. IBA IS REPORTING THIS EVENT PREVENTIVELY AS: IBA DOES NOT KNOW THE CAUSE OF THE ERROR MEASURED BY THE CUSTOMER, AND IBA CANNOT ENSURE THAT EVEN AFTER THE TIGHTENING OF THE SCREWS THERE ARE NO HIGHER ERRORS ON OTHER POINTS OF THE TREATMENT VOLUME THAN THE ONE VERIFIED WITH THE "REALISOOFFSET VALIDATION" PROCEDURE. 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 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 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, AND THEREFORE, IBA CONSIDERS THAT, BY ACQUIRING X-RAY IMAGES ON OTHER POINTS OF THE TREATMENT VOLUME, THE USER WOULD BE ABLE TO DETECT INTERMEDIATE ERRORS. BASED ON THIS INFORMATION, IBA EVALUATES THAT THE RISK OF MAJOR INJURY IS NOT REMOTE (RISK OF MISALIGNMENT OF A FEW MILLIMETERS).
IBA REFERENCE: NCIPT-11871 DESCRIPTION OF THE EVENT: ON (B)(6)2023, IBA WAS INFORMED THAT THE ISOCENTRICITY TEST PERFORMED BY THE CUSTOMER FAILED FOR THE PATIENT POSITIONING SYSTEM (PPS) IN GANTRY TREATMENT ROOM 4. IBA TIGHTENED THE SCREWS OF THE AXES 3 AND 4 OF THE PPS TO CORRECT A SLIPPAGE VISIBLE ON THESE AXES. THEN, IBA CARRIED OUT THE "REALISOOFFSET VALIDATION" PROCEDURE TO VERIFY THE PPS ACCURACY. THE MEASUREMENTS WERE WITHIN THE IBA TOLERANCE OF 1MM. 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. IBA IS REPORTING THIS EVENT PREVENTIVELY AS: 1) IBA DOES NOT KNOW THE MAXIMUM ERROR THAT WAS MEASURED BY THE CUSTOMER WHEN THE ISOCENTRICITY TEST WAS CARRIED OUT, AND 2) IBA CANNOT ENSURE THAT EVEN AFTER THE TIGHTENING OF THE SCREWS THERE ARE NO HIGHER ERRORS ON OTHER POINTS OF THE TREATMENT VOLUME THAN THE ONE VERIFIED WITH THE "REALISOOFFSET VALIDATION" PROCEDURE. UPDATES ON JULY 12, 2023: ON APRIL 26, THE CUSTOMER MEASURED A MAXIMUM ERROR IN POSITION OF 7,8 MM WHEN THE ISOCENTRICITY TEST WAS CARRIED OUT. IBA IS INVESTIGATING THIS ERROR IN POSITION. 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 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, AND THEREFORE, 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 (MISTREATMENT DUE TO MISALIGNMENT UP TO 5 MM) AS POSSIBLE. IBA RISK AND TECHNICAL EXPERTS ARE DEFINING A STRATEGY TO FURTHER QUANTIFY THE SAFETY RISK. UPDATE ON (B)(6), 2023: A MAXIMUM ERROR IN POSITION OF 7,8 MM WAS MEASURED BY THE CUSTOMER ON APRIL 26. UPDATES ON (B)(6) 2023: THE SEQUENCE OF EVENTS WAS AS FOLLOWS: - ON (B)(6) THE CUSTOMER DETECTED AN ERROR WITH THE PPS DURING X-RAY IMAGE ACQUISITION AND PERFORMED PPS ISOCENTRICITY TESTS. THE MAXIMUM ERROR IN POSITION MEASURED WAS 7,8 MM (AT PPS ANGLE 90°). - ON THE SAME DAY, IBA TEAM ON SITE INVESTIGATED THE ISSUE AND FOUND A VISIBLE SLIPPAGE ON AXES 3 AND 4 OF THE PPS. TIGHTENING THE SCREWS RESPONSIBLE OF THIS SLIPPAGE CORRECTED THE ERROR IN POSITION. - THE "REALISOOFFSET VALIDATION" PROCEDURE WAS PLAYED BY THE IBA TEAM ON SITE (B)(6) AND THE RESULTS WERE WITHIN THE IBA TOLERANCE OF 1 MM FOR THE SINGLE POINT OF THE TREATMENT VOLUME TESTED. BASED ON THIS SEQUENCE OF EVENTS, IBA CONCLUDES THAT THE CAUSE OF THIS ERROR IN POSITION WAS THE UNTIGHTENED SCREWS ON AXES 3 AND 4 OF THE PPS. IBA RISK AND TECHNICAL EXPERTS ARE DEFINING A STRATEGY TO FURTHER QUANTIFY THE SAFETY RISK.
IBA REFERENCE: (B)(4). DESCRIPTION OF THE EVENT: ON (B)(6) 2023, IBA WAS INFORMED THAT THE ISOCENTRICITY TEST PERFORMED BY THE CUSTOMER FAILED FOR THE PATIENT POSITIONING SYSTEM (PPS) IN GANTRY TREATMENT ROOM 4. IBA TIGHTENED THE SCREWS OF THE AXES 3 AND 4 OF THE PPS TO CORRECT A SLIPPAGE VISIBLE ON THESE AXES. THEN, IBA CARRIED OUT THE "REALISOOFFSET VALIDATION" PROCEDURE TO VERIFY THE PPS ACCURACY. THE MEASUREMENTS WERE WITHIN THE IBA TOLERANCE OF 1MM. 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. IBA IS REPORTING THIS EVENT PREVENTIVELY AS: 1) IBA DOES NOT KNOW THE MAXIMUM ERROR THAT WAS MEASURED BY THE CUSTOMER WHEN THE ISOCENTRICITY TEST WAS CARRIED OUT, AND 2) IBA CANNOT ENSURE THAT EVEN AFTER THE TIGHTENING OF THE SCREWS THERE ARE NO HIGHER ERRORS ON OTHER POINTS OF THE TREATMENT VOLUME THAN THE ONE VERIFIED WITH THE "REALISOOFFSET VALIDATION" PROCEDURE. UPDATES ON JULY 12, 2023: ON (B)(6), THE CUSTOMER MEASURED A MAXIMUM ERROR IN POSITION OF 7,8 MM WHEN THE ISOCENTRICITY TEST WAS CARRIED OUT. IBA IS INVESTIGATING THIS ERROR IN POSITION. 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 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, AND THEREFORE, 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 (MISTREATMENT DUE TO MISALIGNMENT UP TO 5 MM) AS POSSIBLE. IBA RISK AND TECHNICAL EXPERTS ARE DEFINING A STRATEGY TO FURTHER QUANTIFY THE SAFETY RISK. UPDATE ON JULY 12, 2023: A MAXIMUM ERROR IN POSITION OF 7,8 MM WAS MEASURED BY THE CUSTOMER ON (B)(6).
IBA REFERENCE: (B)(4). DESCRIPTION OF THE EVENT: ON APRIL 27, 2023, IBA WAS INFORMED THAT THE ISOCENTRICITY TEST PERFORMED BY THE CUSTOMER FAILED FOR THE PATIENT POSITIONING SYSTEM (PPS) IN GANTRY TREATMENT ROOM 4. IBA TIGHTENED THE SCREWS OF THE AXES 3 AND 4 OF THE PPS TO CORRECT A SLIPPAGE VISIBLE ON THESE AXES. THEN, IBA CARRIED OUT THE "REALISOOFFSET VALIDATION" PROCEDURE TO VERIFY THE PPS ACCURACY. THE MEASUREMENTS WERE WITHIN THE IBA TOLERANCE OF 1MM. 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. IBA IS REPORTING THIS EVENT PREVENTIVELY AS: 1) IBA DOES NOT KNOW THE MAXIMUM ERROR THAT WAS MEASURED BY THE CUSTOMER WHEN THE ISOCENTRICITY TEST WAS CARRIED OUT, AND 2) IBA CANNOT ENSURE THAT EVEN AFTER THE TIGHTENING OF THE SCREWS THERE ARE NO HIGHER ERRORS ON OTHER POINTS OF THE TREATMENT VOLUME THAN THE ONE VERIFIED WITH THE "REALISOOFFSET VALIDATION" PROCEDURE. UPDATES ON JULY 12, 2023: ON (B)(4), THE CUSTOMER MEASURED A MAXIMUM ERROR IN POSITION OF 7,8 MM WHEN THE ISOCENTRICITY TEST WAS CARRIED OUT. IBA IS INVESTIGATING THIS ERROR IN POSITION. 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 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, AND THEREFORE, 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 (MISTREATMENT DUE TO MISALIGNMENT UP TO 5 MM) AS POSSIBLE. IBA RISK AND TECHNICAL EXPERTS ARE DEFINING A STRATEGY TO FURTHER QUANTIFY THE SAFETY RISK. A MAXIMUM ERROR IN POSITION OF 7,8 MM WAS MEASURED BY THE CUSTOMER ON (B)(4). UPDATES ON AUGUST 31, 2023: THE SEQUENCE OF EVENTS WAS AS FOLLOWS: - ON (B)(4), THE CUSTOMER DETECTED AN ERROR WITH THE PPS DURING X-RAY IMAGE ACQUISITION AND PERFORMED PPS ISOCENTRICITY TESTS. THE MAXIMUM ERROR IN POSITION MEASURED WAS 7,8 MM (AT PPS ANGLE 90°). - ON THE SAME DAY, IBA TEAM ON SITE INVESTIGATED THE ISSUE AND FOUND A VISIBLE SLIPPAGE ON AXES 3 AND 4 OF THE PPS. TIGHTENING THE SCREWS RESPONSIBLE OF THIS SLIPPAGE CORRECTED THE ERROR IN POSITION. - THE "REALISOOFFSET VALIDATION" PROCEDURE WAS PLAYED BY THE IBA TEAM ON SITE ((B)(4)) AND THE RESULTS WERE WITHIN THE IBA TOLERANCE OF 1 MM FOR THE SINGLE POINT OF THE TREATMENT VOLUME TESTED. BASED ON THIS SEQUENCE OF EVENTS, IBA CONCLUDES THAT THE CAUSE OF THIS ERROR IN POSITION WAS THE UNTIGHTENED SCREWS ON AXES 3 AND 4 OF THE PPS. IBA RISK AND TECHNICAL EXPERTS ARE DEFINING A STRATEGY TO FURTHER QUANTIFY THE SAFETY RISK. UPDATES ON OCTOBER 30, 2023: 1) REGARDING THE MAXIMUM ERROR IN POSITION OF 7.8 MM MEASURED ON (B)(4), THE CAUSE OF THIS ERROR WAS THE UNTIGHTENED SCREWS ON AXES 3 AND 4 OF THE PPS. IBA CONSIDERS THAT THIS UNTIGHTENED SCREWS ON AXES 3 AND 4 OF THE PPS CAN INDUCE A RISK OF A NON-DETECTED ERROR IN POSITION BETWEEN 5 AND 10 MM. HOWEVER, THIS ERROR IN POSITION COULD BE DETECTED: - BY ACQUIRING A NEW SET OF X-RAY IMAGES TO VERIFY PROPER POSITIONING OF THE PATIENT AFTER APPLYING AND IMPLEMENTING THE CORRECTIONS CALCULATED BY THE PATIENT POSITION VERIFICATION SYSTEM SOFTWARE, AS RECOMMENDED IN THE IBA PROTON THERAPY SYSTEM CLINICAL USER'S GUIDE, - DURING QA PERFORMED BY THE CUSTOMER, - DURING THE "REALISOOFFSET VALIDATION" PROCEDURE CARRIED OUT BY IBA ON A MONTHLY BASIS AS PER THE PREVENTIVE MAINTENANCE PLAN. BASED ON THE ABOVE INFORMATION, IBA CONSIDERS THAT THERE IS NO RISK OF SERIOUS INJURY INTRODUCED BY THE UNTIGHTENED SCREWS ON AXES 3 AND 4. 2)REGARDING THE ERROR RELATED TO THE "REALISOOFFSET VALIDATION" PROCEDURE PLAYED ON A SINGLE POINT OF THE TREATMENT VOLUME, IBA CARRIED OUT AN ANALYSIS OF PPS ABSOLUTE ACCURACY ERRORS COLLECTED ON THE WHOLE TREATMENT VOLUME AFTER SEVERAL PAST COLLISION EVENTS. THE RESULTS OF THE ANALYSIS SHOWED THAT, AFTER A COLLISION WITH THE PPS, THERE IS A HIGH PROBABILITY THAT SEVERAL POSITIONS OVER THE WHOLE TREATMENT VOLUME MAY EXCEED THE 1 MM ERROR THRESHOLD. AFTER THE RETIGHTENING OF THE SCREWS ON AXES 3 AND 4, THE "REALISOOFFSET VALIDATION" PROCEDURE PASSED (MEASUREMENTS WERE WITHIN THE IBA TOLERANCE OF 1MM). HENCE, BASED ON THE IBA STUDY, IBA EVALUATES THAT THE WORST CASE OF POSITION ERROR AFTER THIS EVENT IS 1.8 MM. THEREFORE, IBA CONCLUDES THAT THERE IS NO RISK OF SERIOUS INJURY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1575773 | PROTEUSPLUS | PROTON THERAPY SYSTEM | LHN | IBA (ION BEAM APPLICATIONS) | PROTEUS235 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown | Other |