ENS 47577
ENS Event | |
|---|---|
05:00 Jan 6, 2012 | |
| Title | Agreement State Report Involving a Potential Medical Event During Brachytherapy |
| Event Description | The following information was received from the State of Ohio via email:
The Ohio Department of Health Bureau of Radiation Protection received a preliminary telephone report from the University of Toledo of a device malfunction with a Varian HDR with an Ir-192 source. A patient had received four treatments to the cervix. The physician noticed during examination reddening of the skin on the upper thigh. Upon reviewing the setup with the tandems, a constriction and blockage was identified in the catheters caused by wear debris. It is presumed at the time being that this caused the system to conclude the source had reached the end of the catheter when it had not. Dose calculations are in the process of being reviewed, however the licensee believes that the doses may be less than the quantities for a medical event. The licensee is The University of Toledo, Ohio license number 02110 49 0006. The licensee is preparing a written report. The Bureau will be sending an inspector to the site next week. Ohio Report # OH-12-001
The following information was received by email: The Ohio Department of Health, Bureau of Radiation Protection is updating the event report to indicate that this is a medical event. An Ohio Department of Health Bureau of Radiation Protection inspector investigated the incident at the licensee facility on Thursday Jan. 12, 2012. The Varian HDR (model number AL19000001, SN VS0054) had 4.01 Ci of Ir-192 at the time of the incident and was using the Brachyvision treatment system. After the fourth of four fractions of 400 cGy each, the attending physician noticed an unusual skin reaction. After licensee was unable to find any errors in the treatment delivered, they began to investigate the hardware. The licensee found a 'corrosion' line in the entry of the Tandem used in the Fletcher Suite Device where the device narrows at is end. During the fourth fraction, apparently the catheter inserted into the tandem snagged on the 'corrosion' causing the starting point of fraction treatment to be misplaced 9 cm. The treatment began from this point, not at the intended treatment site. Preliminary dose calculations were made based on the assumption that the starting dwell position was at this point instead of being fully inserted. Preliminary dose calculations indicate a skin dose of 1251 cGy to the right thigh, and 1273.9 cGy to the left thigh when no skin dose was intended. The dose to the prescribed treatment point for that fraction was 194.2 cGy instead of 400 cGy. The total dose for all fractions to the prescribed treatment site was 1394.2 cGy instead of the intended 1600 cGy. The patient and the referring physician have been notified. The physician does not anticipate any adverse effects. The original catheter used is no longer made by Varian, and the licensee was using a replacement catheter that that is slightly larger in diameter and is thicker than the original. The original catheter did not get caught on the 'corrosion' in the Tandem. This issue was found with two Tandems in three Fletcher Suite Device sets. The new catheter fully inserts as intended into the other Tandems. The licensee's corrective action includes marking the new catheters to provide a visual indication that it has been fully inserted into the Tandem." A Medical Event may indicate potential problems in a medical facility's use of radioactive materials. It does not necessarily result in harm to the patient. |
| Where | |
|---|---|
| University Of Toledo Toledo, Ohio (NRC Region 3) | |
| License number: | 02110 49 0006 |
| Organization: | Ohio Bureau Of Radiation Protection |
| Reporting | |
| Agreement State | |
| Time - Person (Reporting Time:+11.68 h0.487 days <br />0.0695 weeks <br />0.016 months <br />) | |
| Opened: | Karl Von Ahn 16:41 Jan 6, 2012 |
| NRC Officer: | Steve Sandin |
| Last Updated: | Jan 13, 2012 |
| 47577 - NRC Website | |
University Of Toledo with Agreement State | |
WEEKMONTHYEARENS 485922012-11-27T05:00:00027 November 2012 05:00:00
[Table view]Agreement State Agreement State Report - Underdose to Prescribed Treatment Location Following a Brachytherapy Treatment ENS 475772012-01-06T05:00:0006 January 2012 05:00:00 Agreement State Agreement State Report Involving a Potential Medical Event During Brachytherapy 2012-11-27T05:00:00 | |