BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RAYSTATION

    MDR report key: 18354641 · Received December 19, 2023

    Report

    Report Number
    3007774465-2023-00035
    Event Type
    Injury
    Date Received
    December 19, 2023
    Date of Event
    November 20, 2023
    Report Date
    March 17, 2025
    Manufacturer
    RAYSEARCH LABORATORIES AB (PUBL)
    Product Code
    MUJ
    PMA / PMN Number
    K222312
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE CUSTOMER USES RAYSTATION TOGETHER WITH RAYCARE. THEY WERE USING TWO RAYCARE CASE PLANS FOR THE SAME RAYSTATION CASE AND QUOTE THIS AS A CONTRIBUTING CAUSE OF THE USE ERROR. THERE IS NO SUPPORT FOR RAYCARE CASE PLANS IN RAYSTATION. THIS IS AS DESIGNED AND DESCRIBED, BUT ADDING SUPPORT FOR RAYCARE CASE PLANS IN RAYSTATION COULD POTENTIALLY MAKE SIMILAR USE ERRORS LESS LIKELY FOR RAYCARE USERS. HOWEVER, VERY FEW RAYSTATION USE RAYCARE, SO THIS WOULD BE INEFFECTIVE FOR MOST USERS. IN THE EVENT THAT INCORRECT PATIENT SETUP INSTRUCTIONS ARE USED AT DELIVERY, THIS COULD LEAD TO LOCAL OVER-DOSE IN A RISK ORGAN AND/OR TOO LOW DOSE TO THE INTENDED TARGET.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED NEAR-MISSES CAUSED BY USE ERRORS FOR TWO PATIENT TREATMENTS. THERE WAS NO MALFUNCTION. NO PATIENTS WERE IMPACTED. EACH PATIENT HAD TWO TARGET SITES FOR TREATMENT AND THE INTENTION WAS TO CONTOUR ONE TARGET ON ONE CT SET AND THE OTHER TARGET ON ANOTHER CT SET. BY MISTAKE BOTH TARGET VOLUMES WERE CONTOURED ON THE SAME CT SET. CONSEQUENTLY, ONE OF THE PLANS WAS CREATED ON THE WRONG CT WITH AN INCORRECT PATIENT POSITION. THE PLAN WAS ALMOST DELIVERED TO THE PATIENT, BUT THE MISTAKE WAS DISCOVERED AT THE LINAC BEFORE TREATMENT AS THE SETUP INSTRUCTIONS DID NOT MATCH WITH THE POSITION ON THE CBCT.

    Description of Event or Problem · 0

    FOLLOW-UP OF REPORT RSL MDR: 3007774465-2023-00035 126971 (B)(6) POTENTIAL SAFETY ISSUE. THE CUSTOMER REPORTED NEAR-MISSES CAUSED BY USE ERRORS FOR TWO PATIENT TREATMENTS. THERE WAS NO MALFUNCTION. NO PATIENTS WERE IMPACTED. EACH PATIENT HAD TWO TARGET SITES FOR TREATMENT AND THE INTENTION WAS TO CONTOUR ONE TARGET ON ONE CT SET AND THE OTHER TARGET ON ANOTHER CT SET. BY MISTAKE BOTH TARGET VOLUMES WERE CONTOURED ON THE SAME CT SET. CONSEQUENTLY, ONE OF THE PLANS WAS CREATED ON THE WRONG CT WITH AN INCORRECT PATIENT POSITION. THE PLAN WAS ALMOST DELIVERED TO THE PATIENT, BUT THE MISTAKE WAS DISCOVERED AT THE LINAC BEFORE TREATMENT AS THE SETUP INSTRUCTIONS DID NOT MATCH WITH THE POSITION ON THE CBCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1164614 RAYSTATION RADIATION THERAPY TREATMENT PLANNING SYSTEM MUJ RAYSEARCH LABORATORIES AB (PUBL) 12A SP1

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other