BEUDAMED
    FDA Adverse Event Other Summary report: N

    IPLAN RT DOSE

    MDR report key: 2625771 · Received June 13, 2012

    Report

    Report Number
    8043933-2012-00007
    Event Type
    Other
    Date Received
    June 13, 2012
    Date of Event
    April 17, 2012
    Report Date
    April 17, 2012
    Manufacturer
    BRAINLAB AG
    Product Code
    MUJ
    PMA / PMN Number
    K080888
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SINCE THIS LARGE SHIFT WAS OBVIOUS TO THE USER, THE USER DID NOT PROCEED AND THE PLAN WAS NOT USED FOR PT IRRADIATION. THERE WAS NO MISADMINISTRATION OF RADIATION DOSE TO THE PT. BRAINLAB CONCLUSION: ALTHOUGH THERE HAS BEEN NO PT INJURY NOR ANY ADVERSE EVENT REPORTED BY ANY HOSPITAL REGARDING THIS SPECIFIC ISSUE, A RISK TO PT HEALTH COULD NOT BE EXCLUDED. BRAINLAB INVESTIGATION HAS SHOWN THAT WHEN USING THE DICOM "FULL EXPORT" WITHIN IPLAN RT DOSE VERSION 4.1, UNDER SPECIFIC CONDITIONS THE ISOCENTER POSITIONS AND THE RT STRUCTURES EXPORTED FROM IPLAN RT DOSE VERSION 4.1 MIGHT BE INCORRECT. IF NOT RECOGNIZED BY THE USER, AN INCORRECT PT POSITION FOR IRRADIATION MIGHT RESULT. BRAINLAB INTENDS THE FOLLOWING CORRECTIVE ACTIONS (CONCLUDED ON JUNE 1, 2012): EXISTING POTENTIALLY AFFECTED IPLAN RT DOSE VERSION 4.1 CUSTOMERS RECEIVE A PRODUCT NOTIFICATION INFO. BRAINLAB WILL PROVIDE A SOFTWARE UPDATE WITH THIS ISSUE SOLVED TO AFFECTED CUSTOMERS. TENTATIVE PLANNED TIMELINE FOR AVAILABILITY: END OF 2012.

    Description of Event or Problem · 1

    THE USER CREATED A RADIATION THERAPY TREATMENT PLAN WITH THE BRAINLAB IPLAN RT DOSE TREATMENT PLANNING SOFTWARE VERSION 4.1. THIS FULL TREATMENT PLAN WAS EXPORTED FROM THE BRAINLAB SOFTWARE TO ANOTHER, NON-BRAINLAB RADIATION TREATMENT PLANNING SOFTWARE, WITH THE INTENTION TO USE A NON-BRAINLAB PT POSITION METHOD AT THE LINEAR ACCELERATOR. AFTER IMPORT OF THE PLAN INTO THE NON-BRAINLAB PLANNING SOFTWARE, THE USER OBSERVED THAT THE TARGET POSITION (ISOCENTER) AND THE OUTLINED STRUCTURES WERE SHIFTED BY APPROX 7 CM FROM THE ORIGINALLY PLANNED AND INTENDED POSITION. SINCE THIS LARGE SHIFT WAS OBVIOUS TO THE USER, THE USER DID NOT PROCEED AND THE PLAN WAS NOT USED FOR PT IRRADIATION. THERE WAS NO MISADMINISTRATION OF RADIATION DOSE TO THE PT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1