BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MRIDIAN SYSTEMS

    MDR report key: 8430222 · Received March 18, 2019

    Report

    Report Number
    3011233554-2019-00001
    Event Type
    Malfunction
    Date Received
    March 18, 2019
    Date of Event
    February 1, 2019
    Report Date
    May 6, 2019
    Manufacturer
    VIEWRAY, INC.
    Product Code
    IYE
    PMA / PMN Number
    K170751
    Removal / Correction Number
    3011233554-03-06-2019-1C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL MANUFACTURER NARRATIVE: DATE REC¿D BY MFR - (B)(6) 2019. THIS FOLLOW-UP REPORT ADDS THE RECALL NUMBER ASSOCIATED WITH THIS REPORTED EVENT. OTHER SERIOUS (IMPORTANT MEDICAL EVENTS) WAS INADVERTENTLY CHECKED ON THE INITIAL REPORT - THE COMPLAINANT CONFIRMED THAT THERE WAS NO SERIOUS INJURY FOR THE PATIENT. THE REPORTED EVENT OCCURRED WITH A MODEL 20000; THE INITIAL MDR INCLUDED MODEL 10000 IN ERROR. THIS WAS A FOREIGN EVENT REPORT; THE INITIAL MDR DID NOT HAVE "FOREIGN" CHECKED.

    Description of Event or Problem · 1

    WHEN PERFORMING A FRACTION REVIEW OF A PATIENT TREATMENT ON THE MRIDIAN LINAC THE USER BECAME AWARE THAT THE PATIENT WAS TREATED WITH 2.5GY (GRAY) PER FRACTION OVER 6 FRACTIONS FOR A TOTAL OF 15GY INSTEAD OF THE INTENDED 2GY PER FRACTION FOR A TOTAL OF 12GY. THE USER PRESCRIBED A TREATMENT OF 66GY OVER 33 FRACTIONS OF 2GY EACH FOR THE PATIENT. THE USER INITIATED TREATMENT USING A NON-MRIDIAN LINAC SYSTEM (A VARIAN TRUEBEAM SYSTEM). THE PATIENT RECEIVED 14GY OVER 7 FRACTIONS USING THE VARIAN SYSTEM. THE USER DECIDED TO MOVE THE TREATMENT REGIMEN FOR THE PATIENT FROM THE TRUEBEAM SYSTEM TO THE MRIDIAN LINAC SYSTEM. THE USER PRESCRIBED THE REMAINING DOSE OF 52GY ON THE MRIDIAN LINAC AT 52GY OVER 26 FRACTIONS WHICH RESULTED IN REMAINING DOSE AND FRACTIONS AT 2GY EACH. THE USER OPTIMIZED THE PLAN USING THE ORIGINAL 66GY RATHER THAN THE REMAINING 52GY LEFT TO BE TREATED TO SHOW THE FULL DOSE. AS A RESULT, THE PER-FRACTION MU (MONITORING UNIT) WAS CALCULATED AS 66GY OVER 26 FRACTIONS WHICH EQUALS 2.5GY A FRACTION. THE USER DISPLAY CLEARLY INDICATED THAT THEY WERE OPTIMIZING AT 66GY AND NOT THE INTENDED 52GY. THIS DOSE OF 66GY WAS APPROVED BY THE USER IN ERROR. THIS RESULTED IN THE PATIENT RECEIVING 3GY MORE THAN INTENDED, BUT DID NOT EXCEED THE CUMULATIVE TOTAL GY PRESCRIBED. THE EVENT DETAILED IN THIS MDR CONSTITUTES AN ACCIDENTAL RADIATION OCCURRENCE (ARO) AS DEFINED IN 21 CFR 1000.3(A). PER 21 CFR 1002.20(C), THIS MDR FULFILLS THE ARO REPORTING OBLIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    222278 MRIDIAN SYSTEMS RADIATION THERAPY IYE VIEWRAY, INC. 20000 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Other