BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CLINAC 600C

    MDR report key: 2489359 · Received March 8, 2012

    Report

    Report Number
    2916710-2012-00010
    Event Type
    Injury
    Date Received
    March 8, 2012
    Date of Event
    October 15, 2011
    Report Date
    February 14, 2012
    Manufacturer
    VARIAN MEDICAL SYSTEMS, INC.
    Product Code
    IYE
    PMA / PMN Number
    K904364
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT EVALUATED BY VARIAN, BECAUSE VARIAN WAS NOT ABLE TO OBTAIN THE NECESSARY INFO FROM THE FACILITY. VARIAN HAS CONDUCTED AN INVESTIGATION, OBTAINING INFO FROM (B)(6) MEDIA ARTICLES AND FROM THE VARIAN LOCAL SERVICE ORGANIZATION. VARIAN SERVICE HAS STATED THAT THE DEVICE WAS CALIBRATED CORRECTLY, AND THIS HAS BEEN VERIFIED BY AN INDEPENDENT AUDITOR. THE SITE DOES NOT HAVE A TREATMENT PLANNING SYSTEM OR AN ELECTRONIC RECORD-AND-VERIFY SYSTEM IN USE; THE SETTINGS USED FOR TREATMENT DELIVERY ARE CALCULATED BY HAND, OR BY A NON-VARIAN SOFTWARE PROGRAM OPERATED BY THE HOSPITAL STAFF. IT IS BELIEVED THAT AN ERROR WAS MADE, WHERE THE ENTIRE PRESCRIBED DOSE OF 12 GY WAS DELIVERED AT EACH OF THE EIGHT TREATMENT SESSIONS RATHER THAN DIVIDED OVER THE EIGHT FRACTIONS, AS PLANNED. IT IS REPORTED THAT THE PRESCRIBED DOSE OF 150 CGY PER DAY FOR EIGHT FRACTIONS FOR A TOTAL DOSE OF 12 GY, (1200 CGY). IF THE 12 GY WERE DELIVERED AT EACH TREATMENT SESSION, THE TOTAL DELIVERED DOSE WOULD BE 96 GY, WHICH COULD EXPLAIN THE SEVERE REACTION TO THE TREATMENT. NO CORRECTIVE ACTION IS SUGGESTED, AS THERE HAS BEEN NO ALLEGATION OR FINDING OF DEVICE MALFUNCTION. VARIAN DOES NOT EXPECT TO RECEIVE FURTHER INFO ON THIS EVENT, DUE TO LEGAL PROTECTION OF THE INFO BY (B)(6) AUTHORITIES. IF ADD'L INFO IS OBTAINED, A SUPPLEMENTAL MDR WILL BE SUBMITTED. (B)(4).

    Description of Event or Problem · 1

    THE VARIAN SERVICE GROUP IN (B)(4) WAS MADE AWARE OF A REPORTED PT RADIATION OVERDOSE, THROUGH A TELEVISION NEWS ARTICLE BY THE (B)(6) ON (B)(6) 2012. THE NEWS REPORT STATED THAT A (B)(6) FEMALE WAS TREATED TO THE WHOLE BRAIN FOR LEUKEMIA AT THE (B)(6) IN (B)(6) 2011. IT IS REPORTED THAT THE PT DEMONSTRATED SEVERE REACTIONS TO THE TREATMENT BY THE LAST, (8TH), FRACTION OF TREATMENT. THE REACTIONS STARTED WITH SKIN BURNS THAT WERE NOT EXPECTED AND LED TO LOSS OF BOTH EARS, THIRD DEGREE BURNS OF THE HEAD AND NECK, PARTS OF THE SKULL EXPOSED, AND SEVERE NEUROLOGICAL DAMAGE. THERE HAS BEEN NO ALLEGATION OR FINDING OF MALFUNCTION OF THE VARIAN CLINAC 600 AT THE SITE. THE FACILITY HAS DECLINED TO SUPPLY FURTHER INFO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CLINAC 600C ACCELERATOR, LINEAR, MEDICAL IYE VARIAN MEDICAL SYSTEMS, INC. H18

    Patients

    Seq Age Sex Outcome Treatment
    1 7 YR Other| S