BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEVION S250I PROTON THERAPY SYSTEM

    MDR report key: 21159350 · Received January 15, 2025

    Report

    Report Number
    3007087027-2025-00001
    Event Type
    Malfunction
    Date Received
    January 15, 2025
    Date of Event
    February 6, 2024
    Report Date
    February 27, 2025
    Manufacturer
    MEVION MEDICAL SYSTEMS INC.
    Product Code
    LHN
    UDI-DI
    00864366000124
    PMA / PMN Number
    K172848
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MEVION WILL IMPLEMENT A SOFTWARE UPDATE WHICH IS EXPECTED TO REMOVE THE POTENTIAL FOR THIS RACE CONDITION FROM OCCURRING. THIS REPORT HAS BEEN CORRECTED TO CLARIFY THAT WHILE (B)(6) WAS THE SITE THAT INITIALLY REPORTED THE OCCURRENCE AND BROUGHT IT TO MEVION'S ATTENTION, AFTER REVIEWING THE LOGS TREATMENT HAD ONLY OCCURRED IN THIS CONDITION AT (B)(6). IN THE 30-DAY REPORT SUBMITTED JANUARY 15, 2025, IN SECTION B5: DESCRIBE EVENT OR PROBLEM, IT WAS INCORRECTLY STATED THAT "LOG ANALYSIS WAS COMPLETED AND MEVION BECAME AWARE THAT THERE HAVE BEEN 14 OCCURRENCES OF THIS RACE CONDITION OCCURRING AND NOT BEING CAUGHT PRIOR TO TREATMENT. ALL 14 OCCURRENCES WERE AT TWO SITES, ONE SITE IN THE NETHERLANDS, EU (B)(6). AT (B)(6) THERE WERE 4 OCCURRENCES OF THE RACE CONDITION OCCURRING AND TREATMENT CONTINUING ON THE FOLLOWING DATES: (B)(6) 2023 THERE WAS A TREATMENT WITH A 3D POSITIONING ERROR OF 0.00763217 MM (B)(6) 2023 THERE WAS A TREATMENT WITH A 3D POSITIONING ERROR OF 0.0 MM (B)(6), THERE WAS A TREATMENT WITH A 3D POSITIONING ERROR OF 0.00014142 MM (B)(6) 2023 THERE WAS A TREATMENT WITH A 3D POSITIONING ERROR OF 0.0 MM THERE WAS NEVER AN OCCURRENCE OF THE RACE CONDITION WHERE A TREATMENT CONTINUED AT (B)(6) WHERE THE 3D POSITIONING ERROR WAS GREATER THAN .008 MM, WHICH IS WITHIN SETUP TOLERANCES AND IS NOT EXPECTED TO CAUSE ANY HARM." THIS HAS BEEN CORRECTED TO SAY " LOG ANALYSIS WAS COMPLETED AND MEVION BECAME AWARE THAT THERE HAVE BEEN 14 OCCURRENCES OF THIS RACE CONDITION OCCURRING AND NOT BEING CAUGHT PRIOR TO TREATMENT. ALL 14 OCCURRENCES WERE AT TWO SITES IN THE USA (B)(6). THESE EVENTS HAD 3D POSITIONING ERRORS BETWEEN 0 AND 5.3 MM. THERE HAS NOT BEEN AN OCCURRENCE OF THIS RACE CONDITION OCCURRING AND NOT BEING CAUGHT PRIOR TO TREATMENT AT THE REPORTING SITE, (B)(6) IN THE NETHERLANDS. AT (B)(6) THERE WERE 4 OCCURRENCES OF THE RACE CONDITION OCCURRING AND TREATMENT CONTINUING ON THE FOLLOWING DATES: (B)(6) 2023 THERE WAS A TREATMENT WITH A 3D POSITIONING ERROR OF 0.00763217 MM. (B)(6) 2023 THERE WAS A TREATMENT WITH A 3D POSITIONING ERROR OF 0.0 MM. (B)(6), THERE WAS A TREATMENT WITH A 3D POSITIONING ERROR OF 0.00014142 MM. (B)(6), 2023 THERE WAS A TREATMENT WITH A 3D POSITIONING ERROR OF 0.0 MM. THERE WAS NEVER AN OCCURRENCE OF THE RACE CONDITION WHERE A TREATMENT CONTINUED AT (B)(6) WHERE THE 3D POSITIONING ERROR WAS GREATER THAN .008 MM, WHICH IS WITHIN SETUP TOLERANCES AND IS NOT EXPECTED TO CAUSE ANY HARM." ADDITIONALLY, THE UDI FOR THE DEVICE INSTALLED AT (B)(6). (B)(4) WAS ADDED INTO SECTION D4 ADDITIONAL UDIS.

    Additional Manufacturer Narrative · 0

    MEVION WILL IMPLEMENT A SOFTWARE UPDATE WHICH IS EXPECTED TO REMOVE THE POTENTIAL FOR THIS RACE CONDITION FROM OCCURRING.

    Description of Event or Problem · 0

    NOVEMBER 29, 2024: RADIATION THERAPISTS AT THE (B)(6) IN THE NETHERLANDS REPORTED AN ISSUE DURING PATIENT SETUP FOR TWO CASES. AFTER APPLYING THE CBCT DELTAS AND COMPLETING THE SETUP, THEY PERFORMED THE DELTA+SAVE FUNCTION AND TRANSITIONED THE SYSTEM TO THE TREATMENT POSITION. HOWEVER, UPON REACHING THE TREATMENT POSITION, THERE WAS A DEVIATION IN THE DISPLAYED DELTA VALUES FROM THE PLANNED DELTA VALUES, WHICH SHOULD NOT OCCUR. IN SUCH INSTANCES, THE PROTOCOL REQUIRES UNLOADING THE PATIENT AND REPEATING CBCT IMAGING. IN THIS CASE, THE ISSUE WAS IDENTIFIED BEFORE TREATMENT BEGAN, DUE TO THE IMPLEMENTED MITIGATIONS, ENSURING NO HARM OR MISTREATMENT OCCURRED. MEVION REVIEWED THE INCIDENT WHEN IT WAS REPORTED AND DETERMINED IT WAS NOT REPORTABLE BECAUSE THE SAFEGUARDS IN PLACE EFFECTIVELY PREVENTED ANY MISTREATMENT. DECEMBER 13, 2024: MEVION HELD AN INTERNAL MEETING TO REVIEW THE SAFETY ANALYSIS OF THE EVENT AND MEVION DECIDED TO PERFORM A LOG REVIEW FOR ALL S250I DEVICES WITH KRC4 COUCHES INSTALLED TO DETERMINE HOW OFTEN THIS RACE CONDITION PRESENTS AND IF PATIENTS WERE TREATED WITH THE INCORRECT DELTAS APPLIED. DECEMBER 17, 2024 (AWARENESS DATE OF FEBRUARY 6, 2024, INCIDENT): LOG ANALYSIS WAS COMPLETED AND MEVION BECAME AWARE THAT THERE HAVE BEEN 14 OCCURRENCES OF THIS RACE CONDITION OCCURRING AND NOT BEING CAUGHT PRIOR TO TREATMENT. ALL 14 OCCURRENCES WERE AT TWO SITES IN THE USA (MERCY HOSPITAL ST. LOUIS AND KANSAS CITY UROLOGY CENTER). THESE EVENTS HAD 3D POSITIONING ERRORS BETWEEN 0 AND 5.3 MM. THERE HAS NOT BEEN AN OCCURRENCE OF THIS RACE CONDITION OCCURRING AND NOT BEING CAUGHT PRIOR TO TREATMENT AT THE REPORTING SITE, (B)(6) IN THE NETHERLANDS. AT (B)(6) THERE WERE 4 OCCURRENCES OF THE RACE CONDITION OCCURRING AND TREATMENT CONTINUING ON THE FOLLOWING DATES: (B)(6) 2023 THERE WAS A TREATMENT WITH A 3D POSITIONING ERROR OF 0.00763217 MM. (B)(6) 2023 THERE WAS A TREATMENT WITH A 3D POSITIONING ERROR OF 0.0 MM. (B)(6), THERE WAS A TREATMENT WITH A 3D POSITIONING ERROR OF 0.00014142 MM. (B)(6) 2023 THERE WAS A TREATMENT WITH A 3D POSITIONING ERROR OF 0.0 MM. THERE WAS NEVER AN OCCURRENCE OF THE RACE CONDITION WHERE A TREATMENT CONTINUED AT MERCY HOSPITAL ST. LOUIS WHERE THE 3D POSITIONING ERROR WAS GREATER THAN .008 MM, WHICH IS WITHIN SETUP TOLERANCES AND IS NOT EXPECTED TO CAUSE ANY HARM. AT (B)(6) IN THE USA (B)(6), THERE WERE 10 OCCURRENCES OF THE RACE CONDITION OCCURRING AND TREATMENT CONTINUING ON THE FOLLOWING DATES: (B)(6) 2024 THERE WAS A TREATMENT WITH A 3D POSITIONING ERROR OF 4.40814751 MM. (B)(6) 2024 THERE WAS A TREATMENT WITH A 3D POSITIONING ERROR OF 1.00967024 MM. (B)(6) 2024 THERE WAS A TREATMENT WITH A 3D POSITIONING ERROR OF 5.30854323 MM. (B)(6) 2024 THERE WAS A TREATMENT WITH A 3D POSITIONING ERROR OF 1.74964377 MM. (B)(6) 2024 THERE WAS A TREATMENT WITH A 3D POSITIONING ERROR OF 1.36366881 MM. (B)(6) 2024 THERE WAS A TREATMENT WITH A 3D POSITIONING ERROR OF 2.6151209 MM. (B)(6) 2024 THERE WAS A TREATMENT WITH A 3D POSITIONING ERROR OF 0.3592038 MM. (B)(6) 2024 THERE WAS A TREATMENT WITH A 3D POSITIONING ERROR OF 1.50323972 MM. (B)(6) 2024 THERE WAS A TREATMENT WITH A 3D POSITIONING ERROR OF 0.00908881 MM. (B)(6) 2024 THERE WAS A TREATMENT WITH A 3D POSITIONING ERROR OF 1.52912587 MM. AS CAN BE SEEN ABOVE, THERE WERE TWO INSTANCES WHERE THE 3D POSITIONING ERRORS WERE ABOVE 3 MM (4.4 MM AND 5.3 MM), WHICH COULD BE CONSIDERED TREATMENT IN THE WRONG LOCATION AND HAS THE POTENTIAL TO CAUSE MARGINAL HARM. DECEMBER 18, 2024: AFTER ASSESSING THE RESULTS OF THE LOG REVIEW, MEVION BECAME AWARE OF TWO INSTANCES WHERE THE 3D POSITIONING ERRORS WERE ABOVE 3 MM WHICH ARE OUTSIDE OF SETUP TOLERANCES AND COULD BE CONSIDERED TREATMENT IN THE WRONG LOCATION AND POTENTIALLY CAUSE HARM. THERE HAVE BEEN NO HARM OR SIDE EFFECTS REPORTED FOR ANY PATIENTS, HOWEVER MEVION IS REPORTING THIS AS AN ACCIDENTAL RADIATION OCCURRENCE (ARO) SINCE MEVION BECAME AWARE OF AN EVENT RESULTING IN TREATMENT THAT HAD A 3D POSITIONING ERROR OF >3 MM. IT IS IMPORTANT TO NOTE THAT EACH OF THESE POSITIONING ERRORS ONLY HAPPENED ON ONE FRACTION OF ONE TREATMENT FOR EACH PATIENT EACH TIME, SO THERE WERE NO REPEAT TREATMENT ERRORS FOR ANY PATIENTS. ADDITIONALLY, NO HARM OR SIDE EFFECTS HAVE BEEN REPORTED FOR ANY PATIENTS, AT EITHER SITE.

    Description of Event or Problem · 0

    ON (B)(6) 2024: RADIATION THERAPISTS AT (B)(6) CENTER IN THE NETHERLANDS REPORTED AN ISSUE DURING PATIENT SETUP FOR TWO CASES. AFTER APPLYING THE CBCT DELTAS AND COMPLETING THE SETUP, THEY PERFORMED THE DELTA+SAVE FUNCTION AND TRANSITIONED THE SYSTEM TO THE TREATMENT POSITION. HOWEVER, UPON REACHING THE TREATMENT POSITION, THERE WAS A DEVIATION IN THE DISPLAYED DELTA VALUES FROM THE PLANNED DELTA VALUES, WHICH SHOULD NOT OCCUR. IN SUCH INSTANCES, THE PROTOCOL REQUIRES UNLOADING THE PATIENT AND REPEATING CBCT IMAGING. IN THIS CASE, THE ISSUE WAS IDENTIFIED BEFORE TREATMENT BEGAN, DUE TO THE IMPLEMENTED MITIGATION'S, ENSURING NO HARM OR MISTREATMENT OCCURRED. MEVION REVIEWED THE INCIDENT WHEN IT WAS REPORTED AND DETERMINED IT WAS NOT REPORTABLE BECAUSE THE SAFEGUARDS IN PLACE EFFECTIVELY PREVENTED ANY MISTREATMENT. ON (B)(6) 2024: MEVION HELD AN INTERNAL MEETING TO REVIEW THE SAFETY ANALYSIS OF THE EVENT AND MEVION DECIDED TO PERFORM A LOG REVIEW FOR ALL S250I DEVICES WITH KRC4 COUCHES INSTALLED TO DETERMINE HOW OFTEN THIS RACE CONDITION PRESENTS AND IF PATIENTS WERE TREATED WITH THE INCORRECT DELTAS APPLIED. DECEMBER 17, 2024 (AWARENESS DATE OF (B)(6) 2024, INCIDENT): LOG ANALYSIS WAS COMPLETED AND MEVION BECAME AWARE THAT THERE HAVE BEEN 14 OCCURRENCES OF THIS RACE CONDITION OCCURRING AND NOT BEING CAUGHT PRIOR TO TREATMENT. ALL 14 OCCURRENCES WERE AT TWO SITES, ONE SITE IN THE NETHERLANDS, EU (B)(6) CENTER) AND THE OTHER IN THE USA (B)(6) CENTER). THESE EVENTS HAD 3D POSITIONING ERRORS BETWEEN 0 AND 5.3 MM. AT (B)(6) CENTER (S250I-0008) THERE WERE 4 OCCURRENCES OF THE RACE CONDITION OCCURRING AND TREATMENT CONTINUING ON THE FOLLOWING DATES: ON (B)(6) 2023 THERE WAS A TREATMENT WITH A 3D POSITIONING ERROR OF 0.00763217 MM, ON (B)(6) 2023 THERE WAS A TREATMENT WITH A 3D POSITIONING ERROR OF 0.0 MM, (B)(6), THERE WAS A TREATMENT WITH A 3D POSITIONING ERROR OF 0.00014142 MM, ON (B)(6) 2023, THERE WAS A TREATMENT WITH A 3D POSITIONING ERROR OF 0.0 MM. THERE WAS NEVER AN OCCURRENCE OF THE RACE CONDITION WHERE A TREATMENT CONTINUED AT (B)(6) CENTER WHERE THE 3D POSITIONING ERROR WAS GREATER THAN .008 MM, WHICH IS WITHIN SETUP TOLERANCES AND IS NOT EXPECTED TO CAUSE ANY HARM. (B)(6) CENTER IN THE USA (S250I-0015), THERE WERE 10 OCCURRENCES OF THE RACE CONDITION OCCURRING AND TREATMENT CONTINUING ON THE FOLLOWING DATES: ON (B)(6) 2024 THERE WAS A TREATMENT WITH A 3D POSITIONING ERROR OF 4.40814751 MM, ON (B)(6) 2024 THERE WAS A TREATMENT WITH A 3D POSITIONING ERROR OF 1.00967024 MM, ON (B)(6) 2024 THERE WAS A TREATMENT WITH A 3D POSITIONING ERROR OF 5.30854323 MM, ON (B)(6) 2024 THERE WAS A TREATMENT WITH A 3D POSITIONING ERROR OF 1.74964377 MM, ON (B)(6) 2024 THERE WAS A TREATMENT WITH A 3D POSITIONING ERROR OF 1.36366881 MM, ON (B)(6), 2024 THERE WAS A TREATMENT WITH A 3D POSITIONING ERROR OF 2.6151209 MM, ON (B)(6) 2024 THERE WAS A TREATMENT WITH A 3D POSITIONING ERROR OF 0.3592038 MM, ON (B)(6) 2024 THERE WAS A TREATMENT WITH A 3D POSITIONING ERROR OF 1.50323972 MM, ON (B)(6) 2024 THERE WAS A TREATMENT WITH A 3D POSITIONING ERROR OF 0.00908881 MM, ON (B)(6) 2024 THERE WAS A TREATMENT WITH A 3D POSITIONING ERROR OF 1.52912587 MM. AS CAN BE SEEN ABOVE, THERE WERE TWO INSTANCES WHERE THE 3D POSITIONING ERRORS WERE ABOVE 3 MM (4.4 MM AND 5.3 MM), WHICH COULD BE CONSIDERED TREATMENT IN THE WRONG LOCATION AND HAS THE POTENTIAL TO CAUSE MARGINAL HARM. DECEMBER 18, 2024: AFTER ASSESSING THE RESULTS OF THE LOG REVIEW, MEVION BECAME AWARE OF TWO INSTANCES WHERE THE 3D POSITIONING ERRORS WERE ABOVE 3 MM WHICH ARE OUTSIDE OF SETUP TOLERANCES AND COULD BE CONSIDERED TREATMENT IN THE WRONG LOCATION AND POTENTIALLY CAUSE HARM. THERE HAVE BEEN NO HARM OR SIDE EFFECTS REPORTED FOR ANY PATIENTS, HOWEVER MEVION IS REPORTING THIS AS AN ACCIDENTAL RADIATION OCCURRENCE (ARO) SINCE MEVION BECAME AWARE OF AN EVENT RESULTING IN TREATMENT THAT HAD A 3D POSITIONING ERROR OF >3 MM. IT IS IMPORTANT TO NOTE THAT EACH OF THESE POSITIONING ERRORS ONLY HAPPENED ON ONE FRACTION OF ONE TREATMENT FOR EACH PATIENT EACH TIME, SO THERE WERE NO REPEAT TREATMENT ERRORS FOR ANY PATIENTS. ADDITIONALLY, NO HARM OR SIDE EFFECTS HAVE BEEN REPORTED FOR ANY PATIENTS, AT EITHER SITE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1364242 MEVION S250I PROTON THERAPY SYSTEM PROTON BEAM RADIATION THERAPY DEVICE LHN MEVION MEDICAL SYSTEMS INC. MEVION S250I 00864366000124

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown