Semantic search
Jump to navigation
Jump to search
| Start date | Reporting criterion | Title | Event description | System | LER | |
|---|---|---|---|---|---|---|
| ENS 55060 | 8 January 2021 08:00:00 | Agreement State | Underdose to Patient Undergoing Radiation Treatment | The following information was received from the Radiologic Health Branch, California Department of Public Health via email: On Friday, January 8, 2021, the University of California Los Angeles (UCLA) notified the Radiologic Health Branch that a potential medical event involving Y-90 had occurred that day. A liver cancer patient was administered four vials of Y-90 BTG Nordion Inc. TheraSpheres to the patient's liver segments 4, 5, 6 and 7. Segment 4 was prescribed 120 Gy ( 0.86 GBq) and the delivered dose was 110.6 Gy (92.17%). Segment 5 was prescribed 120 Gy (0.86 GBq) and the delivered dose was 113.4 Gy (94.5%). Segment 6 was prescribed 120 Gy (0.86 GBq) and the delivered dose was 111.7 Gy (93.08%). Segment 7 was prescribed 120 Gy (0.86 GBq) and the delivered dose was 50.2 Gy (41.83%), which is less than 20 % of the prescribed amount. Overall, the average of the four administrations to the patient's liver was 80.4%. On January 10, 2021, the Radiologic Health Branch, sent an email to UCLA's Radiation Safety Officer requesting that UCLA's Environmental Health and Safety medical team perform an investigation to try to determine the root cause of the delivery failure for segment 7. They were asked to interview the authorized user and all other personnel attending the procedure and also to provide copies of the authorized user's written directives. The patient was notified of the under-dosage and potential continuation of their cancer treatment. 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 53940 | 14 March 2019 07:00:00 | Agreement State | Agreement State - Under-Dosage to Patient | The following was received via e-mail: On March 15, 2019, the University of California Los Angeles (UCLA) notified the Radiologic Health Branch that a medical event involving Y-90 TheraSphere had occurred on March 14, 2019. A patient was prescribed 120 Gy to the left lobe of their liver with Y-90 TheraSpheres. However, the authorized user (physician) was only able to deliver 80.9 Gy (67.4 percent of the prescribed dose) due to suspected complications with the delivery system. UCLA's Office of Environment, Health and Safety (EH&S) team will continue to investigate and notify the BTG Radiation Safety Officer (RSO) group to examine the delivery system. The patient was notified of the under-dosage and potential continuation of their treatment. The patient was discharged in a stable condition." CA 5010 No.: 031419 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 52460 | 22 December 2016 08:00:00 | Agreement State | Agreement State Report - Medical Undersose | The following report was received via e-mail: On December 22, 2016, UCLA's alternate RSO for UCLA sent an e-mail to an RHB ICE inspector for the Radiologic Health Branch (RHB) to report a medical event, per 10 CFR 35.3045. A patient with metastatic sarcoma of the liver was treated by an authorized user at the medical center with Sirtex SIR-spheres containing yttrium-90 (Y-90) on December 22, 2016. A post treatment dose assessment was completed by radiation safety personnel. The authorized user prescribed 0.2 GBq (5.49 mCi) of Y-90 SIR-spheres to the left lobe of the patient's liver, but only 4.07 mCi or 74.1% was delivered. This underdose of 25.9 % caused a medical event to be reported. The patient was also treated with Y-90 SIR-spheres to the right lobe of the liver in compliance with the physician's written directive. The patient was notified by the physician and UCLA's radiation safety office is investigating the cause of the event. California event: 122216 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 52259 | 22 September 2016 07:00:00 | Agreement State | Agreement State Report - Patient Underdosage of Yttrium-90 | The following report was received from the California Department of Public Health via email: On September 23, 2016, the Radiation Safety Officer of the University of California, Los Angeles (UCLA), contacted the Brea office of the Radiologic Health Branch to report a medical event. A patient was treated with Nordion TheraSpheres containing yttrium-90 (Y-90) on September 22, 2016. The prescribed dose was 100 gray (Gy) to the left lobe of the liver. Upon completing the dose assessment after the treatment, it was discovered that only approximately 50 percent of the intended dosage of Y-90 was delivered to the patient (left lobe of the liver). The remainder of the Y-90 dosage appears to have remained in the delivery system, primarily in the system waste container. The licensee performed surveys to confirm that the areas surrounding the delivery system and patient were not contaminated. The patient has been notified, and the licensee is investigating to determine the cause of the event. CA 5010 Number: 092316 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. |