Event Notification Report for January 06, 2012

AGREEMENT STATE REPORT INVOLVING A POTENTIAL MEDICAL EVENT DURING BRACHYTHERAPY

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


* * * UPDATE FROM KARL VON AHN TO DONALD NORWOOD AT 1101 EST ON 1/13/2012 * * *

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."

Notified R3DO (Orth) and FSME EO (Turtil).

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.

AGREEMENT STATE REPORT - LOST ANALYZER

The following information was received via facsimile:

"[The] Environmental Safety Manager of Louisiana Scrap Metal Recycling notified the [Louisiana] Department of Environmental Quality of a lost Niton XLI 818 Q/serial number 6066 analyzer with 30 mCi of Am-241 on January 6, 2012.

"FINDINGS: The investigation was conducted at Louisiana Scrap Metal Recycling in Lafayette. Contact was made with the Environmental Safety Manager and the [Non-Ferrous Manager], who provided the following information of their internal investigation.

"The facility's investigation revealed that on January 5, 2012, [Employee #1] was scanning a customer's trailer to identify the type metal in the load, with a Niton XLI 818Q/serial number 6066 analyzer with 30 mCi of Am-241. The analyzer was discovered missing the next morning, January 6, 2012 by [Employee #2] at approximately [0900 CST and notified the department at 1048 CST on January 6, 2012 of the missing source. [Employee #2] called [Employee #1] to try to reconstruct his actions of the previous day since he had signed out the analyzer on the utilization log. [Employee #1] stated that he believed that he must have left the analyzer on the trailer of a customer. [Employee #2] called the customer to ask if he had found the analyzer and also the route he took to go home. The customer stated that he had not found the analyzer. [Employee #2] then retraced the route to search for the missing analyzer for approximately eight hours but was not successful. The analyzer is still missing to date, however does not pose a health hazard to the general public.

"In conclusion the licensee did not secure licensed radioactive material from unauthorized removal or access. The above area is contrary to LAC 33:XV.445.A. The licensee failed to maintain constant surveillance to prevent unauthorized use of licensed radioactive material that is in a controlled or unrestrictive area. The above area is contrary to LAC 33:XV.445.B. The licensee also failed to have the minimum of two independent physical controls that form a tangible barrier to secure portable gauges from unauthorized removal, whenever portable gauges are not under the control and constant surveillance of the licensee. The above area is contrary to LAC 33:XV.326.B."

Louisiana Incident Number: LA120002

THIS MATERIAL EVENT CONTAINS A "LESS THAN CAT 3" LEVEL OF RADIOACTIVE MATERIAL

Sources that are "Less than IAEA Category 3 sources," are either sources that are very unlikely to cause permanent injury to individuals or contain a very small amount of radioactive material that would not cause any permanent injury. Some of these sources, such as moisture density gauges or thickness gauges that are Category 4, the amount of unshielded radioactive material, if not safely managed or securely protected, could possibly - although it is unlikely - temporarily injure someone who handled it or were otherwise in contact with it, or who were close to it for a period of many weeks. For additional information go to http://www-pub.iaea.org/MTCD/publications/PDF/Pub1227_web.pdf

This source is not amongst those sources or devices identified by the IAEA Code of Conduct for the Safety & Security of Radioactive Sources to be of concern from a radiological standpoint. Therefore is it being categorized as a less than Category 3 source