BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GAMMAMED PLUS IX (PDR) S/O 321099946

    MDR report key: 8189614 · Received December 21, 2018

    Report

    Report Number
    9612638-2018-00001
    Event Type
    Injury
    Date Received
    December 21, 2018
    Date of Event
    December 7, 2018
    Report Date
    February 12, 2019
    Manufacturer
    VARIAN MEDICAL SYSTEMS
    Product Code
    ONL
    PMA / PMN Number
    K120993
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    VARIAN HAS COMPLETED THE INVESTIGATION INTO THE TWO PREVIOUSLY REPORTED ISSUES AND HAS CONFIRMED THAT THE SOURCE STRENGTH ACTIVITY WAS ENTERED IN THE TREATMENT PLANNING SYSTEM AS A HIGH DOSE RATE (HDR) SOURCE ACTIVITY AND THE CUSTOMER PLANNED TREATMENT FOR PATIENTS USING THE HDR FRACTIONATED TREATMENT, BUT DELIVERED TREATMENT USING A SINGLE CHANNEL GYN (GYNECOLOGIC) WITH PDR (PULSE DOSE RATE) SYSTEM AND PDR SOURCE ACTIVITY. THE INVESTIGATION HAS CONCLUDED THAT: 1. NEITHER THE PLANNING SYSTEM, NOR THE AFTERLOADER MALFUNCTIONED; 2. 17 PATIENTS WERE TREATED; 3. TREATED PATIENTS RECEIVED 10% OF THE PRESCRIBED DOSE DUE TO THE ISSUES DESCRIBED ABOVE; AND 4. VARIAN¿S MEDICAL PROFESSIONAL ASSESSMENT OF INJURY (IF ANY) IS INCONCLUSIVE. VARIAN HAS RECEIVED NO REPORTS OF PATIENT INJURY. ALTHOUGH VARIAN ATTEMPTED TO OBTAIN SUFFICIENT INFORMATION TO COMPLETE ITS MEDICAL ASSESSMENT, IT WAS UNABLE TO OBTAIN SUCH INFORMATION. THE ISSUE WAS CAUSED BY THE OCCURRENCE OF ALL THE FOLLOWING EVENTS: THE VARIAN SERVICE ENGINEER FAILED TO FOLLOW PROCEDURE BY NOT ENTERING THE CORRECT SOURCE ACTIVITY INTO THE SYSTEM, PER VARIAN DOCUMENT (B)(4). THE CLINICAL STAFF INCORRECTLY PLANNED TO DELIVER AN HDR COURSE OF TREATMENT USING A PDR SOURCE ACTIVITY. THE CLINICAL STAFF FAILED TO VERIFY THE DELIVERY PARAMETERS WITH THE TREATMENT PLAN PARAMETERS. THE IFU OR RELEASE NOTES INSTRUCT THE CLINICAL STAFF TO VERIFY THAT THE SOURCE ACTIVITY USED FOR TREATMENT PLANNING AND THE SOURCE ACTIVITY FOR TREATMENT DELIVERY ARE CONSISTENT AND FURTHER PROVIDES INSTRUCTIONS THAT INDICATE HOW TO VERIFY THE SOURCE ACTIVITY. THE CLINICAL STAFF FAILED TO IMPLEMENT TREATMENT PLANNING QUALITY ASSURANCE AS DESCRIBED BY THE EUROPEAN GUIDELINES FOR QUALITY ASSURANCE IN BRACHYTHERAPY, BOOKLET NUMBER 8: A PRACTICAL GUIDE TO QUALITY CONTROL OF BRACHYTHERAPY EQUIPMENT, CHAPTER 9 QUALITY ASSURANCE OF BRACHYTHERAPY TREATMENT PLANNING SYSTEMS. THE OPERATOR COULD DETERMINE THE DELIVERED DOSE WAS 10 TIMES LOWER THAN THE PLANNED AND INTENDED DOSE BY COMPARING THE DELIVERY REPORT FROM THE AFTERLOADER TO THE TREATMENT PLANNING DATA WITH APPROPRIATE POST TREATMENT QA. VARIAN IS ADDRESSING THE ISSUE WITH NC-2019-00003. CORRECTIVE ACTIONS INCLUDE RETRAINING OF VARIAN SERVICE PERSONNEL INVOLVED.

    Description of Event or Problem · 0

    REFERENCE MW (B)(4).

    Description of Event or Problem · 1

    TWO ISSUES ARE UNDER INVESTIGATION: 1ST ISSUE: SOURCE STRENGTH WAS ENTERED INCORRECTLY INTO THE TREATMENT PLANNING SYSTEM, AND THE RESULTING PLANNED ACTIVITY WAS NOT VERIFIED IN THE TREATMENT DATA. THIS HAS RESULTED IN 22 PATIENTS POTENTIALLY RECEIVING ONLY 10 PERCENT OF THE PRESCRIBED DOSE. 2ND ISSUE: CUSTOMER HAS TREATED SINGLE CHANNEL GYN (GYNECOLOGIC) WITH PDR PULSE DOSE RATE) SYSTEM AND PDR SOURCE ACTIVITY, BUT USED THE UNIT TO TREAT HDR (HIGH DOSE RATE) FRACTIONATED TREATMENTS. PULSE DOSE RATE IS DELIVERED IN SHORT 'PULSES' OVER SEVERAL HOURS (24-48) WITH SOURCE STRENGTH BETWEEN 10 AND 20 TIMES LOWER THAN HDR. HDR TREATMENTS ARE TYPICALLY DELIVERED IN 3 TO 5 FRACTIONS OVER SEVERAL DAYS. VARIAN HAS MADE THE SITE AWARE OF THE POTENTIAL UNDERDOSE THAT WAS GIVEN FOR THE 22 PATIENTS TREATED. VARIAN HAS MADE SITE AWARE OF THE DIFFERENCE BETWEEN PDR AND HDR TREATMENTS. SITE HAS NOT REPORTED ANY PATIENT INJURIES TO VARIAN TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1029021 GAMMAMED PLUS IX (PDR) S/O 321099946 BRACHYTHERAPY SYST REMOTE AFTERLOADER ONL VARIAN MEDICAL SYSTEMS GM

    Patients

    Seq Age Sex Outcome Treatment
    1 Other