BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELEKTA SYNERGY

    MDR report key: 17395161 · Received July 26, 2023

    Report

    Report Number
    3015232217-2023-00045
    Event Type
    Malfunction
    Date Received
    July 26, 2023
    Date of Event
    May 5, 2023
    Report Date
    February 26, 2024
    Manufacturer
    ELEKTA SOLUTIONS AB
    Product Code
    IYE
    PMA / PMN Number
    K210500
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION WAS COMPLETED BY CONDUCTING A THOROUGH EVALUATION OF THE PRODUCT AND THE REPORTED INFORMATION. THE CUSTOMER REPORTED THAT THEY EXPERIENCED A FACILITY 1STATE ERROR PART WAY THROUGH A VMAT (VOLUME MODULATED ARC THERAPY) ARC, INTERRUPTING TREATMENT DELIVERY. IN ORDER TO INVESTIGATE THE DETAILS OF THE EVENT AND IDENTIFY THE ROOT CAUSE, THE SYSTEM DIAGNOSTIC DATA (SDD) LOGS ARE REQUIRED. UNFORTUNATELY, IT HAS NOT BEEN POSSIBLE RETRIEVE THE SDD COVERING THE DATE OF THE EVENT AS THESE SDD'S ARE PERIODICALLY OVERRIDDEN. HOWEVER, FROM THE DESCRIPTION OF THE EVENT, THERE IS A HIGH PROBABILITY THAT THE EVENT IS SIMILAR TO "DOSE RUNAWAY". ELEKTA HAVE IDENTIFIED THAT IT IS POSSIBLE FOR THE DISPLAYED DELIVERY MU TO RISE TO THE PRESCRIBED DOSE FOLLOWING AN ABNORMAL DOSE DIFF TERMINATION. THE INTEGRITY SOFTWARE WILL SHOW AN ERROR AND REPORT THE ABNORMAL TERMINATION TO THE R&V SYSTEM (MOSAIQ WILL DISPLAY AN ERROR). NO MISTREATMENT SHOULD RESULT PROVIDING THE CUSTOMER FOLLOW'S THE INSTRUCTIONS IN THE CLINICAL USER MANUAL ("CONTINUING TREATMENT DELIVERY AFTER AN ABNORMAL TERMINATION): "DO NOT CONTINUE UNLESS YOU RECORD THE VALUE OF THE BEAM MU DISPLAY WHEN AN ABNORMAL TERMINATION OF A FIELD OCCURS. IN THE R&V SYSTEM, MAKE SURE THAT THE REMAINING MU TO DELIVER IN THE PARTIAL FIELD IS CORRECT BEFORE YOU CONTINUE. IF YOU IGNORE THIS WARNING, YOU CAN CAUSE CLINICAL MISTREATMENT." A PRODUCT BULLETIN (ELEKTA REF: (B)(4)) ADVISING CORRECT ACTIONS IN CASE OF 'DOSE RUNAWAY' WAS ISSUED TO CUSTOMERS WHEN THIS ISSUE WAS RECOGNIZED. THE PRODUCT BULLETIN WAS SENT TO THE CUSTOMER ON 7TH JANUARY 2019. THE USER WAS ABLE TO CORRECT THE RECORD IN MOSAIQ BASED ON THE MU ON THE BACKUP COUNTER AND COMPLETE THE PARTIAL TREATMENT.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THAT THEY EXPERIENCED A FACILITY 1STATE ERROR PART WAY THROUGH A VMAT (VOLUME MODULATED ARC THERAPY) ARC, INTERRUPTING TREATMENT DELIVERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    636689 ELEKTA SYNERGY ACCELERATOR, LINEAR, MEDICAL IYE ELEKTA SOLUTIONS AB

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown