ENS 54882

From kanterella

Jump to navigation Jump to search

v t e ENS Event
04:00 Sep 2, 2020
Title		Agreement State Report - Medical Event - Underdose
Event Description	The following was received from the Georgia Radioactive Materials Program via email: At the end of the administration of Y-90 SIR Spheres [for the treatment of tumors in the right lobe of the liver], the delivery vial (D-Vial) appeared to overfill as the radiologist was attempting to mix the spheres with a 50/50 solution of contrast and 5 percent dextrose/glucose (D5W). The radiologist noticed some clumping and after attempting to gently disperse the Spheres, he gave a couple hard pushes of the contrast/D5W into the D-Vial. At that time, he noticed the leak. He examined the septum and found it to be dry. As a precaution the radiologist put Durabond on top of the septum. Further examination showed that the material leaked out of the sides of the crimped vial top rather than the septum. The procedure was stopped to prevent further contamination. The event occurred while using SIRTEX new SIROS delivery system. The SIRTEX representative was present providing guidance to the radiologist as this was the first time he used the new system. It is estimated that 75 percent of Y-90 SIR-Spheres were administered to the patient [Prescribed Activity: 3.1 GBq (83.7 mCi); Delivered Activity (estimated): 2.87 Gbq (77.7 mCi)]. It is likely that the residual activity was over estimated due to contamination of the SIROS delivery dome. The usual waste from the procedure is contained in a 1-liter Nalgene containers and then placed in a Lucite shield for dose rate measurements to determine the residual activity. The Siros delivery dome could not be measured in the same geometry and likely resulted in an increased dose rate and underestimate of the total dose delivered. At this time, the prescribing physician indicated he does not expect any adverse effects for the patient and is awaiting the dosimetry evaluation from the patients PET/CT Scan. Attempts have been made to recreate the event without success. There is speculation regarding the size of the dose and that the number of Spheres may have been a factor (larger than typically administered). Representatives from SIRTEX indicate that this has not been an issue at other sites. Prior and subsequent studies with the new SIROS delivery system were successful with less activity. Further evaluation of the equipment to determine why the vial leaked, will be performed following decay and return the manufacturer. Georgia Incident Number: 30 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 54882 +/-
Where
Georgia Radioactive Material Pgm Newman, Georgia (NRC Region 1)
License number:	GA 1632-1
Organization:	Georgia Radioactive Material Pgm
Reporting

Agreement State
Time - Person (Reporting Time:+59.02 h2.459 days <br />0.351 weeks <br />0.0808 months <br />)
Opened:	Irene Bennett 15:01 Sep 4, 2020
NRC Officer:	Jeffrey Whited
Last Updated:	Sep 4, 2020
54882 - NRC Website
v • d • e

v t e Emergency Notification System
Georgia Radioactive Material Program with Agreement State
WEEKMONTHYEAR		Agreement State Report - Medical Event - Underdose	Agreement State Report - Loss of Medical Seed After Removal from Patient	2022-08-23T16:00:00 [Table view]
[ENS list for Georgia Radioactive Material Program]

Retrieved from "https://kanterella.com/w/index.php?title=ENS_54882&oldid=3085891"

ENS Notification