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| Start date | Reporting criterion | Title | Event description | System | LER | |
|---|---|---|---|---|---|---|
| ENS 55970 | 29 June 2022 15:00:00 | Agreement State | Medical Event | The following was received from the Illinois Emergency Management Agency (the Agency) via email: Representatives of Elmhurst Hospital (RML IL-01612-01) contacted the Agency at approximately 1230 CDT today, 6/29/22, to report a Y-90 Theraspheres administration that took place on 6/29/22 (approximately 1000 CDT) which resulted in 100 percent of the dose prescribed not being delivered. The pre and post surveys of the vial and delivery system were nearly identical, supporting the licensee's assertion that no microspheres were delivered. The patient was surveyed post-administration and was at background. While contamination was identified on the draping, it resulted from the disconnection of the delivery system when the administration was halted. No contamination was identified on the patient. Microspheres were observed clustered at the hub and none beyond. The licensee claims there were no kinks and the manufacturer's checklist was followed to include agitation/flushing. At this time, it is unclear if the patient and referring physician have been notified, but the licensee is aware of the requirement. The licensee is aware of the 15-day written report requirement. The AU ((Authorized User)) will be back in the office on Friday and understands the Agency will need additional information via a reactionary inspection. The Agency is scheduling a reactive inspection and this report will be updated as information becomes available. Illinois Item Number: IL220023
The Agency conducted a reactive inspection on 7/1/22. At that time, no indications of root cause could be identified. The licensee's written report was received timely and presented no new information. The delivery kit was returned to the manufacturer for assessment when decayed. Subsequent information was submitted to the Agency for review. The licensee's written report was received timely. Documentation included Gamma camera images of the administration set up kit and catheter which appeared to show activity in the microcatheter. Based on images reviewed, the Agency cannot rule out that some activity may have been delivered to the patient. Due to the contamination, not all of the activity in the waste was able to be accounted for; however, the bulk of activity in the waste indicated that conservatively less than 8.9% of the dosage was delivered. Agency inspectors determined the potential root cause as clumping of microspheres between the D and E lines of the administration kit pending investigation/assessment of the administration kit by the manufacturer. The Agency will continue to monitor additional information provided by the licensee. This matter may be considered closed. Notified R3DO (Hills) and NMSS Event Notification via email. 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 55781 | 9 March 2022 06:00:00 | Agreement State | Underdose to Patient | The following information was provided by the Illinois Emergency Management Agency (the Agency) via email: The radiation safety officer (RSO) for Elmhurst Hospital contacted the Agency on 3/10/22 to advise of a Y-90 microsphere administration in which the patient received only 54 percent of the prescribed dose. The administration occurred on the morning of 3/9/22. The physician felt the delivered dose was clinically effective and no further treatment is planned. No adverse patient impacts are expected. The referring physician and patient were notified as required. Agency staff have requested copies of the written directive and associated documentation as details regarding the prescribed activity were not immediately available. Of note, the RSO advised that the authorized user felt resistance during administration and discontinued the procedure. Microspheres were reportedly observed `clumped' within the first two inches of the delivery catheter. A second, smaller vial was obtained and the written directive modified. No contamination or other issues were identified. The Agency will dispatch inspectors, likely at the beginning of next week, to review the procedure and determine root cause. Compliance with Agency regulations regarding modification to a written directive will be reviewed. This matter will be reported under NMED number IL220008. 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. |