Semantic search
| Start date | Reporting criterion | Title | Event description | System | LER | |
|---|---|---|---|---|---|---|
| ENS 57171 | 12 June 2024 21:00:00 | 10 CFR 35.3045(a)(1) | Medical Event - LUTETIUM-177 Misadministration | The following information was provided by the licensee via phone and email: A Lu-177 administration was performed on June 12, 2024. The administration team did not start the patient on amino acids prior to the administration. Upon discovery of the error, the acids were started and ran for 4 hours. This resulted in an unintended dose to the kidneys. The radiation safety officer (RSO) and staff were notified on June 12, 2024. They determined it was a medical event on Jun 12, 2024 at 1600 CDT. The event was reported to the Nuclear Regulatory Commission at 1620 CDT on June 12, 2024. The dose calculation, which is still being estimated by the health physicist, falls under 10 CFR 35.3045 Subpart M Item (a)(1)(i): `a dose to the skin or an organ or tissue other than the treatment site that exceeds 50 rem of the dose expected from the administration defined in the written directive'.
The following information was provided by the licensee via email: Avera McKennan Hospital, would like to retract this medical event notification that was issued on Wednesday, June 12, 2024, under our radioactive material license number 40-16571-02. After further investigating into Subpart M Section 35.3045, report and notification of a medical event, our event only falls under one of the criteria under (iii) "A dose to the skin or an organ or tissue other than the treatment site that exceeds by: (A) 0.5 (50 rem) or more than expected dose to that site from the procedure if the administration had been given in accordance with the written directive prepared or revised before administration; and (B) 50 percent or more the expected dose to that site from the procedure if the administration had been given in accordance with the written directive prepared or revised before administration. Per the Lutathera package insert, the critical organ is the kidneys. The estimated absorbed dose per unit activity to the kidneys is, 0.654 Gy per GBq. The total activity given to patient was 196.6 mCi of lutitium-177. (Based on the activity) given to the (patient, the) estimated absorbed intended dose to the kidneys is 475 rem per unit activity if the amino acids were given. The delivered dose to the kidney was 698 rem (best case scenario calculation). This would fall under Subpart M section 35.3045 (iii) (A): `A dose to the organ exceeds by 0.5 Sv (50 rem).' However, according to the Lutetium package insert, `The co-administration of amino acids reduced the median radiation dose to the kidneys by 47 percent'. When we calculate 50 percent of our intended dose of 475 rem, we get 237 rem. The difference between the intended dose of 475 rem and the delivered dose of 698 rem is 223 rem which is under the under (iii) (B) 50 percent or more of the expected dose. For this to be a medical event, both criteria's under (iii) need to be met. The Avera McKennan Hospital Lutathera event, does not fall under (iii)(B). Notified R4DO (Josey) and NMSS Events (Email) 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. | ||
| ENS 47599 | 16 January 2012 23:00:00 | 10 CFR 35.3045(a)(1) | Medical Event Due to Potential Different Fractional Dose Delivered than Prescribed | The licensee provided notification that a patient received 2 occurrences of a dose less than prescribed when delivering ten fractions of a treatment. Each of the underdoses were approximately 50% of the 340 Gray prescribed fractional dose. The patient will receive additional dose fractions in order to achieve the written directive total dose. The Radiation Oncologist has notified the patient and attending physician.
On January 17, 2012 the NRC Operations Center was verbally notified of two Therapeutic Underdose Occurrences discovered by the licensee on January 16 and 17, 2012. These occurrences involved a fractionated Breast High Dose Rate Afterloader (HDR) treatment with a SenoRx Contura multicatheter breast applicator. The first and third delivered treatment fractions were found to be less than 50% of the intended fractional dose. The entire course of the treatment in the written directive included ten equal-dose fractions of 3.4 Gray per fraction for a total dose of 34 Gray to the prescribed treatment site. To correct for the underdose occurrences, two additional treatment fractions were added and the treatment plan was modified to achieve the total dose specified in the written directive. The licensee now believes that this medical event has also caused an unintended dose to skin outside of the prescribed treatment site, requiring notification under 10CFR35.3045(a)(3). The licensee has performed computer simulation, calculations and physical measurements using TLDs simulating the treatment geometry to model the unintended skin dose. The event delivered an unintended skin dose exceeding at least the skin erythema threshold (2 Gy). The licensee is continuing to monitor the patient response to the skin dose and is working to refine the unintended skin dose estimates. An NRC reactive inspection team is on-site. Notified R4DO (Jeff Clark) and FSME (Greg Suber)
The licensee confirmed that they agree with their medical consultants' findings that the patient received approximately 2720 rads of unintended skin dose. Notified R4DO (Gaddy) and FSME (McIntosh). 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. |