ENS 46189
ENS Event | |
|---|---|
05:00 Aug 18, 2010 | |
| Title | Illinois Agreement State Report - Medical Event Involving Yttrium-90 Under Dose |
| Event Description | The following information was obtained from the State of Illinois via email:
On the afternoon of August 18, [REDACTED], the licensee's Radiation Safety Officer [RSO] called the Agency [Illinois Emergency Management Agency] to report a medical event in accordance with 32 Ill. Adm. Code 336.1080. The licensee was conducting a treatment involving the use of colloidal Y-90 'SIR-Spheres' under consultation with the manufacturer's representative. A dose of 15.4 milliCi was prescribed by the authorized user and the entire volume of material appeared to be delivered without any unexpected complications, including a complete repeated flushing of the delivery line. However, measurements of the associated tubing, vial and other contaminated items in accordance with accepted procedures showed a notable quantity of Y-90 remained. It was subsequently determined that the dose received was less than 80% of the intended dose. [The RSO] contacted the Agency within the prescribed notification period after verifying the measurements and calculations. The Medical Center also notified the attending physician and the patient the same day. Estimates are that 72% [11.1 milliCi] of the intended dose was delivered. [The RSO] was advised of the regulatory reporting requirements and was beginning preparations for providing that information. Initially, it is believed that the underdose will not have any adverse effect on the patient. The prescribed treatment was intended as a palliative measure for liver tumors secondary to colon cancer. [The RSO] was asked to obtain the opinion of the manufacturer's rep as to the cause of the underdose and any recommended corrective actions the manufacturer suggests in these treatments. [The RSO] was also requested to provide the initial corrective action the hospital intends to take for this and subsequent treatments. A separate conversation was held with the authorized physician user [REDACTED] who attended and oversaw the patient treatment. [The physician] advised that there were no spills, leaks, adverse patient reactions or shunting of the dose outside of the hepatic artery that led to the underdose. Comments from all involved at the time of the treatment, including the manufacturer's representative, was that the administration of the palliative treatment was as good as could be expected and there were no visual indications that any anomalies were present in delivery of the dose. Patient will undergo PET and CT scans in 6 weeks and 12 weeks respectively to determine if any additional actions are warranted such as making up the difference in dose, conducting a repeat of the treatment or if taking no action at all is appropriate. The overriding issue will be the patient's general quality of life. At this point, preliminary indications are that no changes in procedures or processes are necessary and that general delivery system design, coupled with characteristics of material to be administered, resulted in the unintended coagulation and accumulation of microspheres either within the Sir-Sphere three way stopcock or the microcatheter despite routine agitation of the suspension delivery vial. Illinois Case Number: IL10055 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. |
| Where | |
|---|---|
| Rush Presbyterian St. Lukes Medical Center Chicago, Illinois (NRC Region 3) | |
| License number: | IL-01766-01 |
| Organization: | Illinois Emergency Mgmt. Agency |
| Reporting | |
| Agreement State | |
| Time - Person (Reporting Time:+35.93 h1.497 days <br />0.214 weeks <br />0.0492 months <br />) | |
| Opened: | Daren Perrero 16:56 Aug 19, 2010 |
| NRC Officer: | Howie Crouch |
| Last Updated: | Aug 19, 2010 |
| 46189 - NRC Website | |
Rush Presbyterian St. Lukes Medical Center with Agreement State | |
WEEKMONTHYEARENS 461892010-08-18T05:00:00018 August 2010 05:00:00
[Table view]Agreement State Illinois Agreement State Report - Medical Event Involving Yttrium-90 Under Dose 2010-08-18T05:00:00 | |