BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NOVALIS TX

    MDR report key: 2630783 · Received June 22, 2012

    Report

    Report Number
    2916710-2012-00024
    Event Type
    Injury
    Date Received
    June 22, 2012
    Date of Event
    June 6, 2012
    Report Date
    June 15, 2012
    Manufacturer
    VARIAN MEDICAL SYSTEMS, INC.
    Product Code
    IYE
    PMA / PMN Number
    K070094
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    VARIAN'S INVESTIGATION HAS DETERMINED THAT THE INCIDENT WAS CAUSED BY USE ERROR. VARIAN'S MEDICAL ADVISER RENDERED A MEDICAL EVALUATION AND DETERMINED THAT THIS EVENT HAS OR MAY HAVE CAUSED OR CONTRIBUTED TO A SERIOUS INJURY. BRAINLAB PROVIDED THE CUSTOMER WITH A FIELD SAFETY NOTICE ON (B)(4) 2009, THAT FAILURE TO MOUNT AND VERIFY THE CORRECT, INTENDED SRS CONICAL COLLIMATOR MAY LEAD TO SERIOUS INJURY OR DEATH. ADDITIONALLY, BRAINLAB INDICATED THAT IT HAD SENT THE CUSTOMER UPDATED BRAINLAB INSTRUCTIONS FOR USE WITH THIS INFO ON (B)(4) 2010 (DELIVERY CONFIRMATION (B)(4) 2010). IN ADDITION, VARIAN ALSO PROVIDED THE CUSTOMER WITH AN URGENT FIELD SAFETY NOTICE DATED (B)(4) 2009, WHICH WAS RECEIVED BY THE CUSTOMER ON (B)(4) 2010. THIS VARIAN DOCUMENT ALSO WARNED THE CUSTOMER THAT THESE MACHINES HAVE NO MECHANISMS FOR VERIFYING THAT THE CONICAL COLLIMATOR IS INSTALLED AND THAT USERS ARE RESPONSIBLE FOR ENSURING CORRECT MOUNTING OF THE CONICAL COLLIMATOR PRIOR TO TREATMENT. A SECOND URGENT FIELD SAFETY NOTICE, DATE (B)(4) 2011, WAS RECEIVED BY THE SITE ON (B)(4) 2011, REITERATING THIS WARNING AND ADVISING THE SITE THAT IT WOULD BE RECEIVING A HARDWARE SOLUTION, THE BARCODE CONICAL COLLIMATOR VERIFICATION (BCCV), 510(K) (B)(4). THIS ACTIVE RECALL IS REPORTED UNDER THE GUIDELINES OF 21 CFR PART 806, (B)(4). IN CASE OF MULTI-VENDOR ENVIRONMENT (SUCH AS SITE IN QUESTION), DEPLOYMENT OF BCCV IS DEPENDENT ON VERIFICATION AND VALIDATION ACTIVITIES OF THIRD-PARTIES, AND THESE ACTIVITIES ARE IN PROGRESS. A SIMILAR EVENT WAS PREVIOUSLY REPORTED BY VARIAN IN MDR 2916710-2009-0031,(B)(4). NO FOLLOW-UP TO THIS MDR ((B)(4)) IS EXPECTED.

    Description of Event or Problem · 1

    AN ALLEGED MISADMINISTRATION OF RADIATION DOSE OCCURRED AT (B)(6), WHERE A STEREOTACTIC RADIOSURGERY (SRS) CONICAL COLLIMATOR ACCESSORY, MFG. BY BRAINLAB, WAS NOT INSERTED IN THE VARIAN LINEAR ACCELERATOR DURING TREATMENT DELIVERY. THE INFO WAS FIRST PROVIDED TO VARIAN'S HELP DESK FROM A (B)(6) BY PHONE. OTHER INFO PROVIDED BY THE STATE INSPECTOR INCLUDED THAT THE CLINIC USES MOSAIQ VERSION 2.3 AND BRAINLAB SRS CONES. HE STATED THAT THE SITE HAD NO INTERLOCK SYSTEM OR BARCODE SYSTEM TO CHECK FOR THE SRS ACCESSORY. NOTE: MOSAIQ IS MANUFACTURED BY THIRD-PARTY (B)(4), AND THE SRS CONES ARE MANUFACTURED BY THIRD-PARTY (B)(4). THE CHIEF RADIATION THERAPIST AT THE SITE INDICATED THE FOLLOWING TO VARIAN BY PHONE: NO CRITICAL STRUCTURES WERE TREATED; A 5X5 CM FIELD WAS USED AND 6 MM CONE FIELD PLANNED; (B)(4) WAS DELIVERED FOR ONE FRACTION TO THE BRAIN; BOTH BEFORE AND AFTER TREATMENT, THE PT HAS REPORTED EXPERIENCING HEADACHES AND THE SITE IS CONTINUING TO MONITOR/FOLLOW THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NOVALIS TX ACCELERATOR, LINEAR, MEDICAL IYE VARIAN MEDICAL SYSTEMS, INC. HTX

    Patients

    Seq Age Sex Outcome Treatment
    1 Other