ENS 42811
ENS Event | |
|---|---|
05:00 Aug 22, 2006 | |
| Title | Agreement State Report - Medical Event |
| Event Description | The State provided the following information via email:
Yesterday [name deleted] the medical physicist for this Aurora, IL based licensee (IL-01207-01) called to report a medical event which had come to her attention. While preparing a 'Mammosite' treatment plan for an upcoming patient, she had found that two previously administered therapy treatments were not as intended (on 7/28/06 and 8/22/06). Both treatment plans called for a dose of 3400 cGy to be administered to each of the patients over 10 fractions at 340 cGy per fraction with two fractions delivered each of 5 days. However, due to confusion and misunderstanding of the data entry into the treatment planning software, an error occurred and the dose per fraction delivered was only 34 cGy for a total treatment dose of only 340 cGy. Thus, both patients received only 10% of the dose they should have received for their cancer treatments. The treatment planning software, named Eclipse, developed by Varian Medical Systems had a known issue with regards to 'fractionated doses'. A company technical bulletin, (CTB-BV-318) had been generated by the company in March of 2003 and provided to its customers alerting them to the appropriate method for data entry for fractionated doses. The technical bulletin for the treatment planning software contains a warning that 'incorrect use could possibly cause a misadministration.' However, Rush Copley did not acquire its high dose rate afterloading system and treatment planning software until August of 2005 and although the treatment planning software had been updated to a newer version, the same issue remained in the new version. According to the authorized user and the medical physicist, there was no training provided on this aspect of use of the treatment planning software when they had attended the manufacturer's training last year. The hospital has administered only these two fractionated doses since they acquired the unit. Both patients have been contacted by the authorized user and the patients are considering the available options for additional treatment if necessary. Considering the treatment regimen is designed for post surgical lumpectomies of the breast, the physician believes the effect of the under dose on the patients will be minimal. The licensee has been advised of the need to file the appropriate report in the next 15 days including its corrective action. Because the dose to the patient differs by more than 20% from that originally prescribed, the Agency must notify the U.S. NRC Operations Center with this event. Patient Information: Patient Number: 1; Patient Informed: Y; Date Informed: 08/28/2006 Therapeutic: BRACHY, REMOTE AFTERLOADER, HDR Organ: BREAST, RIGHT Dose: 340 rad 3.4 Gy; % Dose is Less Than Prescribed: 90 Effect on Patient: OTHER Administered By: PHYSICIAN Patient Number: 2; Patient Informed: Y; Date Informed: 08/28/2006 Therapeutic: BRACHY, REMOTE AFTERLOADER, HDR Organ: BREAST, RIGHT Dose: 340 rad 3.4 Gy; % Dose is Less Than Prescribed: 90 Effect on Patient: OTHER Administered By: PHYSICIAN Source of Radiation: Form of Radioactive: SEALED SOURCE; Radionuclide or Voltage (kVp/MeV): IR-192 Source Use: BRACHYTHERAPY; Activity: 10.2 Ci 377.4 GBq; Manufacturer: ALPH-OMEGA SERVICES Model Number: VS2000; Serial Number: 02-01-0699-001-062106-10250-03 Device/Associated Equipment: Device Name: REMOTE AFTERLOADER HDR Model Number: VARISOURCE Manufacturer: VARIAN Serial Number: VS60037 Reporting Requirements: Reporting Requirement: 32 IAC 335.1080 - Any administration of radioactive materials that results in a 'reportable event' (misadministration), licensee shall notify the agency by telephone NLT next day after licensee ascertains and confirms that a reportable event has occurred. Mode Reported: Telephone |
| Where | |
|---|---|
| Rush Copely Medical Center Aurora, Illinois (NRC Region 3) | |
| License number: | IL-01207-01 |
| Organization: | Illinois Emergency Mgmt. Agency |
| Reporting | |
| Agreement State | |
| Time - Person (Reporting Time:+173.58 h7.233 days <br />1.033 weeks <br />0.238 months <br />) | |
| Opened: | Daren Perrero 10:35 Aug 29, 2006 |
| NRC Officer: | Mike Ripley |
| Last Updated: | Aug 29, 2006 |
| 42811 - NRC Website | |
Rush Copely Medical Center with Agreement State | |
WEEKMONTHYEARENS 428112006-08-22T05:00:00022 August 2006 05:00:00
[Table view]Agreement State Agreement State Report - Medical Event 2006-08-22T05:00:00 | |