ENS 56766
ENS Event | |
|---|---|
05:00 Sep 28, 2023 | |
| Title | Underdose to Patient |
| Event Description | The following was received from the Illinois Emergency Management Agency (the Agency) via email:
On September 29, 2023, the Agency was contacted by Rush University Medical Center of a potential medical event. The administration was determined to be clinically effective with no adverse patient impact reported. The medical event took place on September 28, 2023. The patient and the referring physician were notified within 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br />. The Y-90 Therasphere dose was 23.5 percent less than the prescribed dose. Agency inspectors are scheduled to perform a reactionary inspection on October 3, 2023. Additional information is forthcoming from the licensee and updates will be sent as they are available. Illinois Item Number: IL230027 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.
The following information was provided by the Illinois Emergency Management Agency (the Agency) via email: On September 29, 2023, the Agency was contacted by Rush University Medical Center (IL-01766-01) to advise of a Y-90 Therasphere under dose that occurred the day before. The prescribed dose was 200 Gy and the prescribed activity was 45.92 mCi. The administered dose was 153.1 Gy with an administered activity of 35.15 mCi. This is a 23.5 percent deviation (under dose). The administration was determined to be clinically effective with no adverse patient impact reported. The patient and the referring physician were notified within 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br />. Agency inspectors performed a reactionary inspection on October 3, 2023. The infusion of the Y-90 TheraSpheres went as intended with no identifiable irregularities. Post-admin calculations were performed which calculated that the dose delivered was 35.15 mCi. At this time the [accredited medical practitioner] (AMP) determined the dose delivered was 23.5 percent less than the written directive resulting in a potential medical event. The RSO interviewed all staff involved in the procedure and performed PET/CT imaging of the waste container (with dose vial, administration tubing kit, connector, extension tubing, microcatheter, forceps, etc.). This image was processed, and 3D volume renderings were utilized to identify where hot spots were located within the waste materials. Images of the waste container showed the highest activity was located in the dose vial. No additional apparent issues were discovered by the RSO. During an interview with the AMP, they stated that they tilted the dose vial back and forth to 90 degrees and tapped the vial on a hard surface. After the inspectors reviewed the procedures and through further questioning, they realized that the AMP was not tapping the vial sharply enough against a hard surface. Agency investigation findings identified the root cause of this event as inadequate agitation of the dose vial. Inspectors determined that the tapping process was not performed firmly enough against a hard surface to release the microspheres from the septum of the dose vial. This likely resulted in an increased number of microspheres remaining on the septum of the dose vial, and not released into the solution for administration to the patient. The RSO stated that they had begun the process of revising the checklist utilized during Y-90 TheraSphere procedures to better describe the dose vial preparation which includes the agitation process. Pending no further developments, this matter is considered closed. Notified R3DO (Orth) and NMSS Events Notification (email). |
| Where | |
|---|---|
| Rush University Medical Center Chicago, Illinois (NRC Region 3) | |
| License number: | IL-01766-01 |
| Organization: | Illinois Emergency Mgmt. Agency |
| Reporting | |
| Agreement State | |
| Time - Person (Reporting Time:+33.92 h1.413 days <br />0.202 weeks <br />0.0465 months <br />) | |
| Opened: | Whitney Cox 14:55 Sep 29, 2023 |
| NRC Officer: | Thomas Herrity |
| Last Updated: | Oct 13, 2023 |
| 56766 - NRC Website | |
Rush University Medical Center with Agreement State | |
WEEKMONTHYEARENS 569422024-01-31T06:00:00031 January 2024 06:00:00
[Table view]Agreement State Medical Underdose ENS 567662023-09-28T05:00:00028 September 2023 05:00:00 Agreement State Underdose to Patient ENS 535602018-08-23T05:00:00023 August 2018 05:00:00 Agreement State Illinois Agreement State Report - Medical Event ENS 465432010-11-23T06:00:00023 November 2010 06:00:00 Agreement State Agreement State Report Involving a Medical Event 2024-01-31T06:00:00 | |