BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DOSECHECK (PART OF SUNCHECK)

    MDR report key: 8807351 · Received July 18, 2019

    Report

    Report Number
    MW5088230
    Event Type
    Malfunction
    Date Received
    July 18, 2019
    Date of Event
    July 11, 2019
    Report Date
    July 16, 2019
    Manufacturer
    SUN NUCLEAR CORPORATION
    Product Code
    IYE
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    DOSECHECK SOFTWARE IS USED AS AN EXTERNAL BEAM RADIATION THERAPY SECOND CALCULATION CHECK OF A PT'S TREATMENT PLAN. THE SOFTWARE INCLUDES DATABASE OF PEER REVIEWED PUBLISHED ORGAN DOSE LIMITS THAT CAN BE USED TO VERIFY THAT ORGAN DOSES IN PT'S TREATMENT PLAN ARE WITHIN SAFE LIMITS. AMERICAN ASSOCIATION OF MEDICINE TASK GROUP REPORT 101 (AAPM TG-101) GIVES TOLERANCE DOSES FOR ORGANS AT RISK FOR STEREOTACTIC RADIOSURGERY (SRS) AND STEREOTACTIC RADIOTHERAPY (SRT) TREATMENT TECHNIQUES. AAPM TG-101 IS THE U.S. INDUSTRY STANDARD ORGAN TOLERANCE FOR SRS AND SRT USES HIGH DOSES PER FRACTION IN A SHORT COURSE OF THERAPY OF ONE TO FIVE FRACTIONS. THE TOLERANCES DOSES IN AAPM TG 101 ARE GROUPED BY SERIAL AND PARALLEL ORGANS, AS BOTH HAVE RESPONSES TO RADIATION THERAPY THAT ARE QUANTIFIED DIFFERENTLY. IN AAPM TG-101, SERIAL TISSUES HAVE MINIMUM POINT DOSE TOLERANCES ALONG WITH VOLUME TOLERANCE. THE VOLUME TOLERANCE IS SET TO THE MAXIMUM VOLUME TO WHICH A CERTAIN DOSE CAN BE TOLERATED BY THE ORGAN. FOR EXAMPLE, 4CC OF TRACHEAL/LARGE BRONCHUS CAN RECEIVE NO MORE THAT 16.5 GY IN 5 FRACTIONS. THE PARALLEL TISSUES LISTED IN AAPM TG-101 ARE GIVEN WITH A MINIMUM VOLUME THRESHOLD, INSTEAD OF A MAXIMUM VOLUME THRESHOLD. THIS IS TO ENSURE THAT ENOUGH OF THE PARALLEL ORGAN REMAINS FOR FUNCTION OF THE ORGAN. FOR EXAMPLE, FOR THE RENAL CORTEX 200CC MUST NOT RECEIVE 8.4GY IN ONE FRACTION. THIS MEANS THE SYSTEM SHOULD LOOK UP THE VOLUME RECEIVING 8.4GY AND SUBTRACT THAT VOLUME FROM THE TOTAL VOLUME OF THE RENAL CORTEX TO FIND A MINIMUM CRITICAL VOLUME. THIS VOLUME SHOULD THEN BE AT LEAST 200CC T MAINTAIN BASIC RENAL FUNCTION. IN THE DOSE CHECK SOFTWARE, THE SOFTWARE IS INCORRECTLY HANDLING SERIAL TISSUES, DESPITE STATING THAT IT AAPM TG-101 LIMITS. THIS INCORRECT HANDLING MEANS THAT INSTEAD OF THE MINIMUM VOLUME SPARED, THE SOFTWARE REPORTS THE MAXIMUM VOLUME TO A CERTAIN DOSE, LIKE AA SERIAL TISSUE. THE SYSTEM GIVES A PASS / FAIL RESULT AGAINST A CRITERION FOR PARALLEL TISSUES THAT IS NOT CORRECT. INCORRECT ORGAN LIMITS USED IN THIS SOFTWARE MAY CAUSE PTS TO BE TREATED WITH EXTERNAL BEAM RADIATION THERAPY PLANS THAT ARE NOT SAFE FOR DELIVERY FOR THE LUNGS, LIVER AND RENAL CORTEX. ACCORDING TO AAPM TG-101, THE DOSE TOLERANCE FOR NOT MEETING THE PARALLEL ORGAN TOLERANCES INCLUDE GRADE 3 OR GREATER OF LOSS OF BASIC LUNG FUNCTION, LOSS OF BASIC LIVER FUNCTION, BASIC RENAL FUNCTION OR PNEUMONITIS. THE ORGAN TOLERANCE FEATURE FOR AAPM TG-101 WAS NOT USED AT OUR FACILITY AS A DEFINITIVE CHECK OF THE PLAN (THIS WAS PERFORMED MANUALLY IN THE TREATMENT PLANNING SOFTWARE). NO PTS AT OUR FACILITY WERE AFFECTED BY THIS SOFTWARE ERROR. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    597882 DOSECHECK (PART OF SUNCHECK) ACCELERATOR, LINEAR, MEDICAL IYE SUN NUCLEAR CORPORATION DOSECHECK X 1.3.2 SUNCHECK BUILD 17114

    Patients

    Seq Age Sex Outcome Treatment
    1 1 YR