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| Start date | Reporting criterion | Title | Event description | System | LER | |
|---|---|---|---|---|---|---|
| ENS 56942 | 31 January 2024 06:00:00 | Agreement State | Medical Underdose | The following is a summary of information received by email from the Illinois Office of Nuclear Safety: On January 31, 2024, a medical administration of Y-90 microspheres at Rush University Medical Center failed to deliver the intended dose. A patient had been prescribed 34.99 mCi (500 Gy) of yttrium-90 (Y-90) Theraspheres intended for a liver treatment. The post-administration survey indicated a delivered dose of only 23.05 mCi (330 Gy), which was a 34 percent underdose. The patient and physician were notified the day of the treatment. There was no adverse impact on the patient and the patient will not need to be retreated. The administering physician reported significant resistance in the initial and subsequent flushes. IL NMED Item Number: IL240003 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 56766 | 28 September 2023 05:00:00 | Agreement State | Underdose to Patient | 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 hours. 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 hours. 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). | ||
| ENS 53560 | 23 August 2018 05:00:00 | Agreement State | Illinois Agreement State Report - Medical Event | The following information was received from the State of Illinois via email: The RSO (Radiation Safety Officer) for Rush University Medical Center in Chicago (IL-01766-01) notified the Agency (Illinois Emergency Management Agency, Bureau of Radiation Safety) at approximately 1600 (CDT) today that a reportable event transpired while attempting to administer Y-90 TheraSpheres. The licensee attempted to administer Y-90 to a patient this morning and was unable to move the dose through the tubing to the patient. A different administration route was selected and also met with inability to deliver the dose. This treatment was aborted. A second patient was scheduled for Y-90 administration this afternoon. The licensee encountered resistance in the second delivery system and was unable to deliver the Y-90 dose. This treatment was also aborted. Both patients were imaged and verified to not have been administered any Y-90. The licensee is currently performing a PET (Positron Emission Tomography) scan on the delivery systems to look for occlusions that may have impeded delivery. IEMA (Illinois Emergency Management Agency) staff has requested information on lot numbers for the individual doses. Details are pending from the licensee on root cause and lot numbers. The licensee will not administer any additional doses from this lot number until root cause is identified. Further details are pending. Illinois Item No.: IL180033 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 46543 | 23 November 2010 06:00:00 | Agreement State | Agreement State Report Involving a Medical Event | The following report was received from the State of Illinois via email: On January 13 (2011), the licensee's Radiation Safety Officer contacted the Agency (Illinois Emergency Management) to report an apparent medical event that had been discovered during routine post surgery follow up. A patient had undergone treatment for prostate cancer utilizing permanent brachytherapy I-125 seed placement. A total of 102 seeds were inserted into the region in order to deliver a prescribed dose of 14,500 Rad. Manual insertion of the 0.4 milliCi I-125 seeds was done by ultrasound guided placement of the needle template. A C-arm x-ray scan was done post implant of the 0.4mm x 1mm seeds. Visualization of the seed placement was problematic in the post operation scan. Initial estimates were that the seeds may have been inferior to the ideal placement, but still acceptable. However, engorgement of the surrounding tissue and prostate due to the surgical procedure made visualization difficult and performance of additional dosimetry was deemed inappropriate and of little value. The patient was kept appraised of the situation beginning just prior to discharge and advised of the need for continued follow up. As the patient healed, additional scans were scheduled at the 4 week post treatment mark. Those scans suggested the seed placement to be 4-5 cm inferior of the treatment plan. Although the inferior placement of the seeds resulted in avoiding doses to the rectum and bladder as intended in the original treatment plan, as wells as the urethra, the dose to the prostate was suboptimal. Regions receiving elevated dose were the soft tissue at the base of the penis and the penile bulb. Dosimetry values for dose to the prostate provided by the licensee at this time are rough estimates, but are less than 80% of the intended dose. Currently, the patient is asymptomatic. No prediction of long term effects has been made at this time. Physicians are considering the application of external x-ray beam to provide a more effective treatment to the tumor site. This matter remains under investigation by the licensee and the Illinois Emergency Management Agency. The licensee is obliged to file a written report (to the Illinois Emergency Management Agency) in compliance with the rules within 15 days. Given: Therapeutic Procedure: BRACHY, MANUAL IMPLANT Organ: ND Radiopharmaceutical: Radionuclide: I-125, Activity: 42.7 mCi 1579.9 MBq, Dose: 4400 rad 44 Gy Intended: Therapeutic Procedure: BRACHY, MANUAL IMPLANT Organ: PROSTATE Radiopharmaceutical: Radionuclide: I-125, Activity: 42.7 mCi 1579.9 MBq, Dose: 14500 rad 145 Gy % Dose Exceeds Prescribed: 0 % Dose is Less Than Prescribed: 70 Effect on Patient: UNKNOWN The patient was informed of the underdose. IL Report No.: IL11-004 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. |