BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RAYSTATION

    MDR report key: 16452872 · Received February 28, 2023

    Report

    Report Number
    3007774465-2023-00002
    Event Type
    Malfunction
    Date Received
    February 28, 2023
    Date of Event
    May 13, 2020
    Report Date
    March 5, 2025
    Manufacturer
    RAYSEARCH LABORATORIES AB (PUBL)
    Product Code
    MUJ
    PMA / PMN Number
    K200569
    Removal / Correction Number
    RES 85723
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THERE HAS BEEN NO ADVERSE EVENT REPORTED FOR THE PB DOSE ERROR. HOWEVER, DURING INVESTIGATION OF A REPORTED DISCREPANCY WHEN USING THE MC DOSE ENGINE, A SOFTWARE IMPLEMENTATION ERROR WAS IDENTIFIED. THE CAUSE OF THE SOFTWARE ERROR IS CURRENTLY NOT KNOWN. ROOT CAUSE ANALYSIS IS IN PROGRESS. IN THE EVENT THAT A CLINICAL DECISION IS BASED ON THE INCORRECTLY CALCULATED DOSE, THIS COULD LEAD TO THE APPROVAL OF AN INAPPROPRIATE DOSE PLAN. THIS COULD LEAD TO LOCAL OVER-DOSE FROM ALLOWING TOO HIGH OF A DOSE IN VOLUMES AFFECTED BY SPOTS WITH CENTRAL AXIS OUTSIDE THE EXTERNAL ROI.

    Description of Event or Problem · 0

    DESCRIPTION OF REPORTED ADVERSE EVENT: NO SERIOUS ADVERSE EVENT REPORTED. AN ISSUE WITH THE PROTON PENCIL BEAM DOSE ENGINE WAS FOUND DURING INVESTIGATION OF A REPORT OF AN UNEXPECTED BEHAVIOUR WHEN USING THE PROTON MONTE CARLO DOSE ENGINE. A SOFTWARE ERROR IN THE PROTON PENCIL BEAM (PB) DOSE ENGINE HAS BEEN FOUND. SPOTS FOR WHICH THE CENTRAL AXIS DOES NOT GO THROUGH THE EXTERNAL ROI (I.E. THE REGION OF INTEREST THAT DEFINES THE VOLUME WHERE DOSE CALCULATION SHALL BE PERFORMED) ARE NOT INCLUDED IN THE PB PROTON DOSE CALCULATION EVEN IF PARTS OF THE SPOT FALL INSIDE THE EXTERNAL ROI. THIS LEADS TO AN UNDERESTIMATION OF THE DOSE THAT WOULD BE DELIVERED IN VOLUMES AFFECTED BY SUCH SPOTS. THE MONTE CARLO (MC) PROTON OPTIMIZATION DOSE ENGINE CONTAINS THE SAME BUG, BUT THE FINAL MC DOSE CALCULATION IS CORRECT. A CUSTOMER REPORTED SIGNIFICANT DISCREPANCY BETWEEN OPTIMIZED AND FINAL MC DOSE. THIS IS NOT A SAFETY ISSUE, BUT INVESTIGATION OF THIS REPORT IS WHAT LEAD TO THE DISCOVERY OF THE SAFETY RELATED PB DOSE ERROR. THERE WERE NO DEATHS OR SERIOUS INJURIES RELATED TO THIS MALFUNCTION.

    Description of Event or Problem · 0

    FOLLOW-UP OF REPORT RSL: MDR 3007774465-2023-00002 (B)(6) PROTON DOSE FOR SPOTS OUTSIDE EXTERNAL. DESCRIPTION OF REPORTED ADVERSE EVENT: NO SERIOUS ADVERSE EVENT REPORTED. AN ISSUE WITH THE PROTON PENCIL BEAM DOSE ENGINE WAS FOUND DURING INVESTIGATION OF A REPORT OF AN UNEXPECTED BEHAVIOUR WHEN USING THE PROTON MONTE CARLO DOSE ENGINE. A SOFTWARE ERROR IN THE PROTON PENCIL BEAM (PB) DOSE ENGINE HAS BEEN FOUND. SPOTS FOR WHICH THE CENTRAL AXIS DOES NOT GO THROUGH THE EXTERNAL ROI (I.E. THE REGION OF INTEREST THAT DEFINES THE VOLUME WHERE DOSE CALCULATION SHALL BE PERFORMED) ARE NOT INCLUDED IN THE PB PROTON DOSE CALCULATION EVEN IF PARTS OF THE SPOT FALL INSIDE THE EXTERNAL ROI.THIS LEADS TO AN UNDERESTIMATION OF THE DOSE THAT WOULD BE DELIVERED IN VOLUMES AFFECTED BY SUCH SPOTS. THE MONTE CARLO (MC) PROTON OPTIMIZATION DOSE ENGINE CONTAINS THE SAME BUG, BUT THE FINAL MC DOSE CALCULATION IS CORRECT. A CUSTOMER REPORTED SIGNIFICANT DISCREPANCY BETWEEN OPTIMIZED AND FINAL MC DOSE. THIS IS NOT A SAFETY ISSUE, BUT INVESTIGATION OF THIS REPORT IS WHAT LEAD TO THE DISCOVERY OF THE SAFETY RELATED PB DOSE ERROR. THERE WERE NO DEATHS OR SERIOUS INJURIES RELATED TO THIS MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    560878 RAYSTATION RADIATION THERAPY TREATMENT PLANNING SYSTEM MUJ RAYSEARCH LABORATORIES AB (PUBL) RAYSTATION 4, 4.5, 4.7, 5, 6, 7, 8A, 9B, 9A, 9B, 9B SP1

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other