BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BRACHYVISION

    MDR report key: 2133486 · Received June 15, 2011

    Report

    Report Number
    3003793371-2011-00020
    Event Type
    Injury
    Date Received
    June 15, 2011
    Date of Event
    April 20, 2011
    Report Date
    May 16, 2011
    Manufacturer
    VARIAN MEDICAL SYSTEMS FINLAND OY
    Product Code
    MUJ
    PMA / PMN Number
    K992762
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIST

    Narratives

    Additional Manufacturer Narrative · 1

    REPORTS FROM CUSTOMER SITE. THOUGH THERE WAS A MISADMINISTRATION, THERE HAS BEEN NO SERIOUS INJURY TO THE PT REPORTED. THE CUSTOMER HAS REPORTED THAT THE PT DEVELOPED GRADE 4 DERMATITIS AFTER FRACTION 10 WHEN NORMALLY IT SHOWS UP AFTER FRACTION 15. CURRENTLY, THE DERMATITIS HAS RESOLVED WITH USUAL CORRESPONDING TREATMENT. WITH RESPECT TO BRACHYTHERAPY TREATMENT, IT WAS CONSIDERED AS FINISHED SINCE THE EQUIVALENT ADMINISTERED DOSE WAS THE ORIGINALLY PRESCRIBED DOSE. ROOT CAUSE: THE CUSTOMER HAS ACKNOWLEDGED MAKING AN ENTRY ERROR BY TYPING 500CGY PRESCRIPTION INSTEAD OF 300CGY - HUMAN ERROR / USER ERROR. THE CUSTOMER REPORTED THAT NO OTHER CLINICIAN FILTERS THE FINAL PHYSICIST APPROVED/PRINTED PLAN. THE CUSTOMER HAS ALSO REPORTED THAT THEY WILL IMPLEMENT A CLINICIAN APPROVAL OF THE PHYSICIST FINAL/PRINTED TREATMENT PLAN. THOUGH THERE WAS NO REPORTED SERIOUS INJURY, THE CUSTOMER HAS BEEN RELUCTANT IN PROVIDING ADDITIONAL PT FOLLOW-UP SO VARIAN HAS MADE A DECISION TO SUBMIT THIS EVENT AS AN MDR. NO ADDITIONAL FOLLOW-UP TO THIS MDR IS EXPECTED, HOWEVER, VARIAN WILL CONTINUE TO MONITOR THIS EVENT/CUSTOMER SITE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTEDLY MODIFIED THE PLANNED DOSIMETRY, CHANGED THE PRESCRIPTION DOSE BUT DID NOT CHANGE THE FRACTIONATION SCHEME. PLANNED 18X300CGY=5400CGY IN FRACTIONATION SCHEME OF ALTERNATIVE DAYS (MONDAY/WED/FRIDAY); DELIVERED 4X300CGY + 6X500CGY IN SAME FRACTIONATION SCHEME (MONDAY/WED/FRIDAY). IT IS REPORTED THAT THE CUSTOMER MADE AN ERROR AND TYPED A 500CGY PRESCRIPTION INSTEAD OF 300CGY. THE CUSTOMER REALIZED THE ERROR WHEN THE PT PRESENTED WITH ACUTE TOXICITY AFTER THE 8TH FRACTION. THE TREATMENT STOPPED AFTER 10TH FRACTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BRACHYVISION SYS, PLANNING, RAD.THERAPY TREATMENT MUJ VARIAN MEDICAL SYSTEMS FINLAND OY H6B

    Patients

    Seq Age Sex Outcome Treatment
    1