RAYSTATION
Report
- Report Number
- 3010034862-2023-00029
- Event Type
- Malfunction
- Date Received
- March 8, 2023
- Date of Event
- July 6, 2017
- Report Date
- March 19, 2025
- Manufacturer
- RAYSEARCH LABORATORIES AB (PUBL)
- Product Code
- MUJ
- Product Problem
- Yes
- Report Source
- Distributor report
- Reporter Location
- GM
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
A SOFTWARE ERROR AFFECTING QA (VERIFICATION) PLANS FOR PROTON TREATMENT HAS BEEN IDENTIFIED. WHEN EDITING SNOUT POSITION IN THE QA PREPARATION MODULE, RAYSTATION PRESERVES THE GEOMETRICAL PROPERTIES OF BLOCK AND COMPENSATOR PROJECTED ONTO THE ISOCENTER PLANE. THIS MEANS THAT THE PHYSICAL SIZE OF THE BLOCK AND COMPENSATOR USED FOR DOSE COMPUTATION IN THE RAYSTATION QA PLAN CHANGES, AND CONSEQUENTLY DOSE IN THE QA MODULE MAY BE COMPUTED FOR A PHYSICAL BLOCK AND/OR COMPENSATOR SETUP THAT DIFFERS FROM THE SETUP THAT WAS SPECIFIED IN THE TREATMENT PLAN AND USED FOR QA MEASUREMENTS. IF TREATMENT MU IS SET IS BASED ON DOSE CALCULATED FROM AN ADJUSTED QA PLAN, THE OVERALL TREATMENT DOSE LEVEL COULD BECOME TOO HIGH OR TOO LOW COMPARED TO THE PRESCRIBED DOSE LEVEL. THE POTENTIAL DEVIATIONS ARE SMALL, BUT COULD IN RARE CASES BE UP TO 4%.
NO ADVERSE EVENT HAS OCCURRED. NO PATIENTS WERE AFFECTED. A SOFTWARE ERROR HAS BEEN IDENTIFIED IN THE QA MODULE. SOFTWARE ERROR AFFECTING QA (VERIFICATION) PLANS FOR PROTON TREATMENT. WHEN EDITING SNOUT POSITION IN THE QA PREPARATION MODULE, RAYSTATION PRESERVES THE GEOMETRICAL PROPERTIES OF BLOCK AND COMPENSATOR PROJECTED ONTO THE ISOCENTER PLANE. THIS MEANS THAT THE PHYSICAL SIZE OF THE BLOCK AND COMPENSATOR USED FOR DOSE COMPUTATION IN THE RAYSTATION QA PLAN CHANGES, AND CONSEQUENTLY DOSE IN THE QA MODULE MAY BE COMPUTED FOR A PHYSICAL BLOCK AND/OR COMPENSATOR SETUP THAT DIFFERS FROM THE SETUP THAT WAS SPECIFIED IN THE TREATMENT PLAN AND USED FOR QA MEASUREMENTS.
FOLLOW-UP OF REPORT RSA: MDR 3010034862-2023-00029 20673 RS CHANGING SNOUT POSITION IN QA FOR DOUBLE SCATTERING PLANS CHANGES APERTURE. NO ADVERSE EVENT HAS OCCURRED. NO PATIENTS WERE AFFECTED. A SOFTWARE ERROR HAS BEEN IDENTIFIED IN THE QA MODULE. WHEN EDITING SNOUT POSITION IN THE QA PREPARATION MODULE, EITHER DIRECTLY OR BY ADJUSTING GAP, RAYSTATION PRESERVES THE GEOMETRICAL PROPERTIES OF BLOCK AND COMPENSATOR PROJECTED ONTO THE ISOCENTER PLANE. THIS MEANS THAT THE PHYSICAL SIZE OF THE BLOCK AND COMPENSATOR USED FOR DOSE COMPUTATION IN THE RAYSTATION QA PLAN CHANGES, AND CONSEQUENTLY THE DOSE IN THE QA MODULE MAY BE COMPUTED FOR A PHYSICAL BLOCK AND/OR COMPENSATOR SETUP THAT DIFFERS FROM THE SETUP THAT WAS SPECIFIED IN THE TREATMENT PLAN AND USED FOR QA MEASUREMENTS. FOR PASSIVE PROTON TECHNIQUES (UNIFORM SCANNING, DOUBLE SCATTERING, WOBBLING), RAYSTATION DOES NOT COMPUTE ABSOLUTE DOSE AND THE MONITOR UNIT (MU) FOR TREATMENT MUST BE CALCULATED BASED ON MEASURED OUTPUT. IF THE CALCULATED DOSE FOR A MODIFIED QA PLAN IS USED FOR DETERMINING THE OUTPUT FACTOR, THE RESULTING TREATMENT MU MAY BE WRONG. THE MAGNITUDE OF THE ERROR WILL DEPEND ON THE SIZE OF THE SNOUT ADJUSTMENT AND ON THE BEAM MODEL AND FIELD SETUP. THE MAXIMUM DEVIATION FOUND DURING TESTING IS 4% DOSE DEVIATION. THE ERROR IS NOT EASY TO DETECT IN RAYSTATION, BUT SHOULD BE VISIBLE IN PLAN QA IF COMPUTED DOSE IS COMPARED TO 2D OR LINE DOSE MEASUREMENTS. IN RAYSTATION 6 SP1 AND SP2, ALL PROTON TECHNIQUES SUPPORTING BLOCK AND/OR COMPENSATOR ARE AFFECTED. IN RAYSTATION 6, IT IS NOT POSSIBLE TO EDIT SNOUT POSITION, BUT GAP CAN BE EDITED FOR PROTON PBS AND LINE SCANNING PLANS WITH BLOCK.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 121463 | RAYSTATION | RADIATION THERAPY TREATMENT PLANNING SYSTEM | MUJ | RAYSEARCH LABORATORIES AB (PUBL) | RAYSTATION 6 (INCLUDING SP1 AND SP2) |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |