BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VARISOURCE IX SERIES AFTERLOADER

    MDR report key: 4954266 · Received July 23, 2015

    Report

    Report Number
    1124791-2015-00002
    Event Type
    Malfunction
    Date Received
    July 23, 2015
    Date of Event
    June 23, 2015
    Report Date
    June 23, 2015
    Manufacturer
    VARIAN MEDICAL SYSTEMS
    Product Code
    JAQ
    PMA / PMN Number
    K122236
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE ISSUE WAS REPLICATED BY A VARIAN ENGINEER IN THE LAB. IT WAS DETERMINED THAT THE ROOT CAUSE OF THIS ISSUE IS A CODING ERROR VERSION 1.2.1 OF THE VARISOURCE IX SOFTWARE. VARIAN REF. NUMBER: (B)(4).

    Description of Event or Problem · 1

    A PRODUCT PROBLEM DISCOVERED DURING PT TREATMENT WAS REPORTED TO VARIAN MEDICAL SYSTEMS REGARDING THE VARISOURCE IX AFTERLOADER SOFTWARE. THE USER RECEIVED AN ERROR DURING TREATMENT AND ATTEMPTED TO CLEAR THE ERROR DURING WHICH THE CONTROL SOFTWARE LOGGED THE USER OUT AND REQUIRED THE USER TO LOG BACK IN. THE USER WAS ALSO REQUIRED TO ABORT AND CREATE A PARTIAL FRACTION TO RESUME THE TREATMENT. AFTER SELECTING THE "MAKE NEW FRACTION FROM UNDELIVERED PORTION" TREATMENT RECOVERY OPTION, THE RESULTING FRACTION INCLUDED A CHANNEL WHICH HAD ALREADY BEEN DELIVERED. THE PT WAS NOT AFFECTED BY THIS ISSUE AS THE USER DECIDED TO STOP TREATMENT AND CATCH UP THIS FRACTION AT THE END OF THE TREATMENT COURSE. THERE IS A POTENTIAL RISK OF SEROUS INJURY IF THE SCENARIO OF TREATMENT INTERRUPT DURING AN HDR TREATMENT WERE TO RECUR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    478455 VARISOURCE IX SERIES AFTERLOADER JAQ VARIAN MEDICAL SYSTEMS VERSION 1.2.1

    Patients

    Seq Age Sex Outcome Treatment
    1