BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VARISOURCE IX SERIES AFTERLOADER

    MDR report key: 4704021 · Received April 15, 2015

    Report

    Report Number
    1124791-2015-00001
    Event Type
    Malfunction
    Date Received
    April 15, 2015
    Date of Event
    March 16, 2015
    Report Date
    March 17, 2015
    Manufacturer
    VARIAN MEDICAL SYSTEMS
    Product Code
    JAQ
    PMA / PMN Number
    K122236
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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 IN VERSION 1.2.2. OF THE VARISOURCE IX SOFTWARE. THIS ERROR IS NOT PRESENT IN VERSIONS THAT PRE-DATE 1.2.2. (B)(4).

    Description of Event or Problem · 1

    A PRODUCT PROBLEM DISCOVERED DURING QA TESTING WAS REPORTED TO VARIAN MEDICAL SYSTEMS REGARDING THE VARISOURCE IX AFTER-LOADER SOFTWARE. FOLLOWING A POWER FAILURE THE TREATMENT OF RECOVER OF AN INTERRUPTED FRACTION INCORRECTLY INCLUDES ALL CHANNELS AND DWELL POSITIONS. BOTH THE TREATMENT RECOVERY REPORT AND THE PARTIAL FRACTION CREATED DO NOT REFLECT THE DWELL POSITIONS DELIVERED PRIOR TO THE TREATMENT INTERRUPTION. IF USED FOLLOWING POWER FAILURE, THE CREATED PARTIAL FRACTION PLAN WOULD LEAD TO RETREATMENT OF THE PREVIOUSLY DELIVERED DWELL POSITIONS. NO PATIENT WAS AFFECTED BY THIS ISSUE; HOWEVER, THERE IS A POTENTIAL RISK OF SERIOUS INJURY IF THE SCENARIO OF TREATMENT INTERRUPT DURING AN HDR TREATMENT WERE TO RECUR. THIS ISSUE IS SPECIFIC TO VARISOURCE IX SOFTWARE VERSION 1.2.2.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    252438 VARISOURCE IX SERIES AFTERLOADER BRACHYTHERAPY SYST., REMOTE AFTERLOAD JAQ VARIAN MEDICAL SYSTEMS VERSION 1.2.2.

    Patients

    Seq Age Sex Outcome Treatment
    1