BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MOSAIQ

    MDR report key: 21489368 · Received February 28, 2025

    Report

    Report Number
    2950347-2025-00012
    Event Type
    Injury
    Date Received
    February 28, 2025
    Date of Event
    December 23, 2024
    Report Date
    April 10, 2025
    Manufacturer
    ELEKTA INC
    Product Code
    IYE
    PMA / PMN Number
    K183034
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H11 UPDATED: THE CUSTOMER REPORTED A PROBLEM DURING A PARTIAL TREATMENT THAT HAD BEEN RESCHEDULED DUE TO A PROBLEM WITH THEIR VARIAN TRUEBEAM LINAC. THE INVESTIGATION WAS COMPLETED BY CONDUCTING A THOROUGH EVALUATION OF THE PRODUCT AND THE REPORTED INFORMATION. ON (B)(6) 2024, THERE WAS AN UNDEFINED ISSUE WITH THE CUSTOMER'S THIRD-PARTY VARIAN LINAC, DURING A TREATMENT SESSION. FIELDS CT & 1 & 2 WERE SENT FOR TREATMENT, THE UNDEFINED ISSUE OCCURRED, AND FIELD 1 WAS FULLY TREATED, FIELD 2 WAS PARTIALLY TREATED. MOSAIQ RECORDED THE FIELDS CORRECTLY. THE CUSTOMER TRIED TO MANUALLY RECORD THE PARTIAL TREATMENT FOR FIELD 2 (EVEN THOUGH IT HAD ALREADY BEEN CORRECTLY RECORDED). THE CUSTOMER MADE 3 ATTEMPTS TO MANUALLY RECORD, EACH TIME RECORDING WITH ZERO DOSE, SO NO DOSE WAS COUNTED TOWARDS THE TOTAL DOSE FOR FIELD 2. IT SEEMS THAT THE CUSTOMER TRIED TO MOVE THE GANTRY ANGLE TO THE POSITION WHERE IT WAS STOPPED BEFORE RESUMING THE TREATMENT. THIS IS CONSIDERED USE ERROR. THE CUSTOMER SENT FIELDS CT & 2 TO THE MACHINE FOR TREATMENT. MOSAIQ RECEIVED RECORDS FOR THESE AND RECORDED THEM CORRECTLY, HOWEVER FIELD 2 WAS ONLY PARTIALLY TREATED. THIS TREATMENT WAS DELIVERED AT THE INCORRECT ANGLE. THIS IS CONSIDERED USE ERROR. THE CUSTOMER SENT FIELD 2 AGAIN FOR TREATMENT, AND MOSAIQ RECORDED IT CORRECTLY. THE PATIENT RECEIVED THE CORRECT AMOUNT OF DOSE AS PRESCRIBED, BUT THE CUSTOMER INCORRECTLY MANUALLY RECORDED ADDITIONAL DOSE. THE PARTIAL TREATMENT OF FIELD 2 AT THE INCORRECT ANGLE IS A MISTREATMENT HAS BEEN ASSESSED BY ELEKTA PHYSICS AS FOLLOWS: IN THIS INCIDENT 24 MU FROM A SINGLE FIELD WERE DELIVERED FROM AN INCORRECT GANTRY ANGLE ON A SINGLE DAY OF TREATMENT. THE TOTAL NUMBER OF MU DELIVERED FROM THE FIELD MATCHED THE PLANNED TOTAL. THE TOTAL NUMBER OF PLANNED FIELDS PER DAY WAS 2 AND THE TOTAL NUMBER OF PLANNED TREATMENT DAYS IS 37. THE MISDELIVERED 24 MU REPRESENTS APPROXIMATELY 4% OF THE PLANNED DAILY DOSE AND UNDER 1% OF THE TOTAL PLANNED DOSE. BECAUSE SOME TISSUE WAS IRRADIATED WITH MORE MU THAN PLANNED ON THE DAY OF THE INCIDENT, THIS IS ASSESSED AS AN INSIGNIFICANT RADIATION OVERDOSE. THE MOSAIQ INSTRUCTIONS FOR USE FOR VERSION 2.84 (DID# (B)(4)), SECTION 9.12.2 "COMPLETING A PARTIAL TREATMENT" COVERS HOW TO HANDLE THIS WORKFLOW. IT IS SUGGESTED THAT A TRAINER REVIEW THE COMPLETE PARTIAL WORKFLOW WITH THE CUSTOMER TO HELP AVOID THIS SITUATION FROM RE-OCCURRING. MOSAIQ WAS WORKING AS INTENDED.

    Additional Manufacturer Narrative · 0

    THE MANUFACTURER'S INVESTIGATION IS ON-GOING AND FURTHER INFORMATION WILL BE PROVIDED ONCE THE INVESTIGATION HAS COMPLETED.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED A PROBLEM DURING A PARTIAL TREATMENT THAT HAD BEEN RESCHEDULED DUE TO A PROBLEM WITH THEIR VARIAN TRUEBEAM LINAC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    608025 MOSAIQ ACCELERATOR, LINEAR, MEDICAL IYE ELEKTA INC VERSION 2.84.011

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown