BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BRACHYVISION

    MDR report key: 3854882 · Received May 27, 2014

    Report

    Report Number
    3003793371-2014-00001
    Event Type
    Injury
    Date Received
    May 27, 2014
    Date of Event
    February 25, 2014
    Report Date
    May 2, 2014
    Manufacturer
    VARIAN MEDICAL SYSTEMS, INC.
    Product Code
    MUJ
    PMA / PMN Number
    K102011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A VARIAN FIELD SERVICE ENGINEER WENT TO THE CLINIC AND MADE TESTS ON THE AFTERLOADER REGARDING SOURCE POSITIONING AND CHECKED THE EVENT LOGS (NO FAULT EVENT ON RELATED TREATMENT DATES). ALL OF THE TESTS SHOWED THAT THERE WAS NO FAULT WITH THE AFTERLOADER ITSELF. THE FSE ALSO CHECKED THE LENGTH OF THE APPLICATOR USED FOR TREATMENT AND IT WAS MEASURED AS 136 CM WHICH WAS CORRECT. THE FSE AND THE PHYSICIST THEN REPRODUCED THE TREATMENT USING THE SAME PHYSICIST THEN REPRODUCED THE TREATMENT USING THE SAME BRACHYVISION PLAN USED FOR ONE OF THE AFFECTED PATIENTS AND FOUND AN OFFSET OF APPROXIMATELY 6 CM IN RESPECT TO THE INTENDED TARGET POSITION. THE ORIGINAL TRAINING WAS DELIVERED MORE THAN 14 YEARS AGO TO ONE OF THE PHYSICISTS AT THE SITE. THAT PARTICULAR PHYSICIST LEFT THE SITE A FEW YEARS LATER. ADDITIONAL TRAINING WAS CONDUCTED BY VARIAN PERSONNEL IN 2013, WITH THE A DIFFERENT PHYSICIST WHO DID NOT PARTICIPATE IN THE ORIGINAL TRAINING. LAST MONTH, THAT PHYSICIST LEFT THE SITE AND A NEW PHYSICIST WAS HIRED. THE REMAINING 2 PHYSICISTS HAVE NEVER BEEN ON A VARIAN TRAINING. THEY HAVE TREATED 5 PATIENTS SINCE THE PHYSICIST, WHO HAD BEEN TRAINED BY VARIAN, LEFT ON (B)(6) (3 GYN AND 2 PROSTATE PATIENTS). FOR THE GYN PATIENTS, THEY CHANGED THE DISTANCE TO 120 CM (IN BRACHYVISION), WHICH IS THE MEASURED APPLICATOR LENGTH. FOR THE PROSTATE PATIENTS THEY MEASURED ABOUT 136 CM FOR THE APPLICATOR LENGTH AND DID NOT CHANGE THE LENGTH ON THE BRACHYVISION PLAN TO MATCH. IT IS THE CONCLUSION OF THIS INVESTIGATION THAT THE PRIMARY AND ROOT CAUSE OF THIS ISSUE IS USER ERROR.

    Description of Event or Problem · 1

    TWO PATIENTS WERE TREATED FOR PROSTATE CANCER WITH HDR BRACHYTHERAPY. SEVERAL WEEKS AFTER TREATMENT, THE PHYSICIAN OBSERVED A STRONG SKIN REACTION TO THE PERINEUM FOR BOTH PATIENTS. PATIENT #1 WAS TREATED ON (B)(6) 2014. THE PHYSICISTS MEASURED THE APPLICATOR LENGTH (NEEDLE + TRANSFER GUIDE TUBE (PART NUMBERS PENDING)) TO BE 136CM. THE DEFAULT BRACHYVISION APPLICATOR LENGTH OF 130CM WAS NOT EDITED BY THE CUSTOMER TO EQUAL 136CM PRIOR TO TREATMENT. THE RESULT WAS DELIVERY OF ALL OF THE DWELL POSITIONS 6 CM INFERIOR TO THE INTENDED LOCATIONS. DETAILS REGARDING PATIENT #1 REPORTED UNDER MFR REPORT #3003793371-2014-00002.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    311865 BRACHYVISION SYSTEM, PLANNING, RADIATION THERAPY MUJ VARIAN MEDICAL SYSTEMS, INC. V.11.0.41

    Patients

    Seq Age Sex Outcome Treatment
    1 Other