Event Notification Report for March 18, 2022

EN Revision Imported Date: 3/18/2022

EN Revision Text: AGREEMENT STATE REPORT - UNDERDOSE TO PATIENT

The following information was provided by the Illinois Emergency Management Agency (the Agency) via email:

"The radiation safety officer (RSO) for Elmhurst Hospital contacted the Agency on 3/10/22 to advise of a Y-90 microsphere administration in which the patient received only 54 percent of the prescribed dose. The administration occurred on the morning of 3/9/22. The physician felt the delivered dose was clinically effective and no further treatment is planned. No adverse patient impacts are expected.

"The referring physician and patient were notified as required. Agency staff have requested copies of the written directive and associated documentation as details regarding the prescribed activity were not immediately available. Of note, the RSO advised that the authorized user felt resistance during administration and discontinued the procedure. Microspheres were reportedly observed `clumped' within the first two inches of the delivery catheter. A second, smaller vial was obtained and the written directive modified. No contamination or other issues were identified. The Agency will dispatch inspectors, likely at the beginning of next week, to review the procedure and determine root cause. Compliance with Agency regulations regarding modification to a written directive will be reviewed.

"This matter will be reported under NMED number IL220008."

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.

EN Revision Imported Date: 3/18/2022

EN Revision Text: AGREEMENT STATE - LUTATHERA TREATMENT TERMINATED DUE TO INFUSION LINE LEAK

The following information was provided by the Florida Bureau of Radiation Control (FL BRC) via email:

"Today, 3/10/2022, at 1000 EST, Lutathera treatment was started in a controlled infusion room within the nuclear medicine department of Moffitt Cancer Center with an initial vial assay of 206 mCi, approximately two minutes later the NMT [(nuclear medicine technologist)] noticed a leak in the infusion line and stopped the infusion. Assistance was provided by a fellow technologist and the vial of Lutathera (Lu-177) was re-assayed at 130 mCi. The floor lead technologist notified the prescribing physician and the physician decided to terminate the treatment and to re-treat at a later date. Wipe tests performed by the technologists on the patient including the arm where the IV was showed no evidence of removable contamination. The department supervisor was notified and called the radiation safety officer (RSO) at 1030 EST. The IV was removed from the patient and the tubing was assayed at 36 mCi. The infusion room was surveyed and appropriately decontaminated. Residual waste from decontamination, as well as the vial, lead vial container, and IV/tubing were logged, labeled, and placed into secure storage. An investigation into the cause of the incident will be completed, and corrective actions will be implemented to prevent reoccurrence.

"The prescribing physician spoke with the patient and explained what happened and that there would not be any clinical impact on the patient and no medical risks.

"The referring physician was notified.

"A written report will be provided to the FL BRC, the referring physician, and the individual within 15 days of this event in accordance to 64E-5.345 4(b)."

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.

EN Revision Imported Date: 3/18/2022

EN Revision Text: AGREEMENT STATE REPORT - LOST AM-241 SHIPMENT

The following information was provided by the Illinois Emergency Management Agency (the Agency) via email:

"The Agency was contacted on 3/11/22, by the Radiation Safety Officer for Heuft USA, Inc to advise that a package scheduled to arrive at their Downers Grove, IL facility on or before 3/10/22, had not arrived. This was reported as missing in transit. The 6"x6"x6" excepted package contains approximately 86 mCi of Am-241. The carrier could not immediately locate the package and advised it had not been checked into any of their processing facilities. Last known location was an industrial facility (S.C. Johnson) in Sturtevant, WI on 3/3/22, when it was packaged for transit and picked up by the carrier. The package contained (2) special form model AMC-25 sealed sources containing approximately 43 mCi of Am-241 each. Source serial numbers were 3676CW and 7256LQ. Both sources were contained in the 6"x6"x6" brown cardboard box. As it is an excepted package, it will bear only the terms `UN2910' and `RQ' (reportable quantity), and not radioactive labels. Should the package be opened, there is an aluminum 5"x5" round can filled with foam and two zip lock bags. Each bag contains a shielded source holder with the Am-241 capsules therein. The bags and the can are labeled with a trefoil and the words `Radioactive Material'. Unshielded, the two sources would yield a combined exposure rate of about 15 mR/hour at one foot. This is not an immediate hazard to workers or members of the public that locate the package. There is no indication of intentional theft or diversion."

Item Number: IL220009

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