BEUDAMED
    FDA Adverse Event Other Summary report: N

    IPLAN RT DOSE 4.1.2

    MDR report key: 2214269 · Received July 27, 2011

    Report

    Report Number
    8043933-2011-00019
    Event Type
    Other
    Date Received
    July 27, 2011
    Date of Event
    June 7, 2011
    Report Date
    June 23, 2011
    Manufacturer
    BRAINLAB AG
    Product Code
    MUJ
    PMA / PMN Number
    K080888
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ACCORDING TO THE HOSPITAL, 8 OUT OF THE 37 PLANNED RADIATION FRACTIONS HAVE BEEN DELIVERED TO THE PATIENT WITH THE MLC OPENED INSTEAD OF SHAPING THE RADIATION BEAM AS PLANNED. THE PRIMARY COLLIMATORS INSIDE THE LINEAR ACCELERATOR AT THE PLANNED POSITIONS RESTRICTED THE BEAM SIZE. THE HOSPITAL HAS REVIEWED/SIMULATED THE DOSE DISTRIBUTION DELIVERED AND DOES NOT EXPECT ANY ADVERSE OR NEGATIVE CLINICAL EFFECT TO THE PATIENT. THE ORIGINALLY INTENDED TREATMENT PLAN WAS/IS USED TO CONTINUE TREATMENT OF THIS PATIENT. ACCORDING BRAINLAB MEASURES TO REDUCE THE RISK TO BE AS LOW AS REASONABLY PRACTICABLE ARE ALREADY IN PLACE FOR THIS ALREADY ANTICIPATED POTENTIAL RISK. "HUMAN ERROR" CONTRIBUTED TO THE EVENT IN REGARD TO THE BRAINLAB DEVICE INVOLVED. BRAINLAB IS IN CONTINUED CONTACT WITH THE RESPONSIBLE MANUFACTURER OF THE RECORD AND VERIFY SYSTEM FOR FURTHER INVESTIGATION OF THIS ISSUE. CORRECTIVE AND PREVENTIVE ACTIONS: BRAINLAB INTENDS TO REMIND THIS HOSPITAL OF THE RELEVANT WARNINGS IN THE INSTRUCTIONS FOR USE.

    Description of Event or Problem · 1

    A FRACTIONATED STEREOTACTIC RADIOTHERAPY TREATMENT WITH A MULTILEAF-COLLIMATOR (MLC) WAS PLANNED FOR A PATIENT WITH THE BRAINLAB IPLAN RT DOSE RADIOTHERAPY TREATMENT PLANNING SOFTWARE. THE PLAN WAS TRANSFERRED TO A NON-BRAINLAB RECORD AND VERIFY SYSTEM FOR TREATMENT DELIVERY. THE TREATMENT PLAN INSIDE THE RECORD AND VERIFY SYSTEM DID NOT CONTAIN THE PLANNED MLC DATA. ACCORDING TO THE HOSPITAL, 8 OUT OF THE 37 PLANNED RADIATION FRACTIONS HAVE BEEN DELIVERED TO THE PATIENT WITH THE MLC OPENED INSTEAD OF SHAPING THE RADIATION BEAM AS PLANNED. THE PRIMARY COLLIMATORS INSIDE THE LINEAR ACCELERATOR AT THE PLANNED POSITIONS RESTRICTED THE BEAM SIZE. NO ADVERSE OR NEGATIVE CLINICAL EFFECT TO THE PATIENT IS EXPECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IPLAN RT DOSE 4.1.2 PLANNING SW, RADIATION THERAPY TREATMENT MUJ BRAINLAB AG 21213F

    Patients

    Seq Age Sex Outcome Treatment
    1 Other