BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ECLIPE TREATMENT PLANNING SYSTEM

    MDR report key: 3113607 · Received May 9, 2013

    Report

    Report Number
    3003793371-2013-00003
    Event Type
    Injury
    Date Received
    May 9, 2013
    Date of Event
    January 30, 2013
    Report Date
    February 4, 2013
    Manufacturer
    VARIAN MEDICAL SYSTEMS, INC.
    Product Code
    MUJ
    PMA / PMN Number
    K091492
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    PHYSICIST

    Narratives

    Additional Manufacturer Narrative · 1

    VARIAN'S INVESTIGATION INVOLVED REVIEW OF TREATMENT DATA RECORDS, DEVICE USE, DEVICE FUNCTION, DEVICE LABELING AND CLINICAL IMPACT OF THE EVENT. IT WAS DETERMINED THROUGH THE RESULTS OF THE INVESTIGATION THAT THE CUSTOMER DID NOT FOLLOW VARIAN INSTRUCTIONS FOR USE. THE USER CREATED A MANUAL CONTOUR IN ECLIPSE, BUT DID NOT MODIFY THE DEFAULT HU VALUE FROM -1000 HU (AIR) TO 0 HU (WATER). VARIAN'S USER DOCUMENTATION PROVIDED ADEQUATE INSTRUCTIONS TO CORRECTLY CALCULATE THE DOSE USING THE PHANTOM, ASSIGN CT VALUE FOR THE STRUCTURES, AND HIGHLIGHTS THE IMPORTANCE OF VERIFYING THE DOSE CALCULATION AND DOSE DISPLAY AGAINST INDEPENDENT VERIFICATION METHODS IN TREATMENT PLANNING FOR EXTERNAL BEAM. THE CLINICAL EVALUATION IDENTIFIED ONE PT HAD REC'D A 22% DIFFERENTIAL UNDER DOSE BETWEEN THE PRESCRIBED DOSE AND ACTUAL DELIVERED DOSE. THE 22% DIFFERENTIAL COULD RESULT IN A LOWER BIOLOGICAL EFFECT AND POSSIBLE TREATMENT FAILURE. VARIAN CONCLUDES THE EVENT IS CAUSED BY USER ERROR AND NOT A MALFUNCTION OF THE DEVICE. DEVICE PERFORMED ACCORDING TO SPECIFICATIONS. THE CUSTOMER WILL BE NOTIFIED OF OUR FINDINGS BASED ON THE INVESTIGATION AND CONCLUSIONS OF THE EVALUATION. NO ADD'L FOLLOW-UP TO THIS MDR IS EXPECTED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED INCORRECT DOSE ADMINISTRATION IN FOURTEEN (14) PTS. ONE (1) PT WAS TREATED WITH NON ISOCENTRIC TECHNIQUE, RESULTING IN AN OVERDOSE CLOSE TO 12% HIGHER THAN PRESCRIBED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    202518 ECLIPE TREATMENT PLANNING SYSTEM SYSTEM, PLAANING, RAD THERAPY TREATMENT MUJ VARIAN MEDICAL SYSTEMS, INC. H48

    Patients

    Seq Age Sex Outcome Treatment
    1