BEUDAMED
    FDA Adverse Event Other Summary report: N

    IPLAN RT DOSE

    MDR report key: 3060439 · Received April 11, 2013

    Report

    Report Number
    8043933-2013-00010
    Event Type
    Other
    Date Received
    April 11, 2013
    Date of Event
    December 5, 2013
    Report Date
    December 11, 2012
    Manufacturer
    BRAINLAB AG
    Product Code
    MUJ
    PMA / PMN Number
    K080888
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SINCE THE INCORRECT DOSE CALCULATION WAS OBVIOUS TO THE USER, THE USER DID NOT PROCEED AND THE PLAN WAS NOT USED FOR PATIENT IRRADIATION. THERE WAS NO MISADMINISTRATION OF RADIATION DOSE TO THE PATIENT. BRAINLAB CONCLUSION: ALTHOUGH THERE HAS BEEN NO PATIENT INJURY NOR ANY ADVERSE EVENT REPORTED BY ANY HOSPITAL REGARDING THIS SPECIFIC ISSUE, A RISK TO PATIENT HEALTH COULD NOT BE EXCLUDED. BRAINLAB INVESTIGATION HAS SHOWN THAT IPLAN RT DOSE VERSION 4.0 AND 4.1 MIGHT NOT CORRECTLY REFRESH THE DOSE CALCULATION AFTER CERTAIN MLC SHAPE MODIFICATIONS IF SPECIFIC CONDITIONS ARE MET. THE DOSE CALCULATION IS NOT REFRESHED IN THE PHYSICIAN'S REVIEW AND PHYSICIST'S VERIFICATION TASKS OR WHEN GENERATING THE PRINTOUT OR EXPORTING THE PLAN. IF THE INCORRECT DOSE CALCULATION IS NOT RECOGNIZED BY THE USER, THE ACTUAL DELIVERED TREATMENT DOSE MIGHT BE DIFFERENT FROM THE ONE SHOWN IN THE TREATMENT PLAN. BRAINLAB INTENDS THE FOLLOWING CORRECTIVE ACTIONS (CONCLUDED ON (B)(4) 2013): EXISTING POTENTIALLY AFFECTED CUSTOMERS RECEIVE A PRODUCT NOTIFICATION INFORMATION, BRAINLAB WILL PROVIDE A SOFTWARE UPDATE WITH THIS ISSUE SOLVED TO AFFECTED CUSTOMERS.

    Description of Event or Problem · 1

    WHEN USING IPLAN RT DOSE 4.1 FOR TREATMENT PLANNING, THE USER RECOGNIZED THAT, WHEN CHANGING THE MARGIN PARAMETER, THE DOSE CALCULATION WAS NOT CORRECTLY UPDATED. SINCE THE USER RECOGNIZED THE INCORRECT DOSE CALCULATION, THIS SPECIFIC PLAN WAS NOT USED FOR PATIENT TREATMENT AND ACCORDINGLY THERE WAS NO MISADMINISTRATION OF RADIATION DOSE TO A PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    155436 IPLAN RT DOSE RADIATION THERAPY TREATMENT PLANNING SYS MUJ BRAINLAB AG 21213F NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other