Event Notification Report for August 11, 2021

EN Revision Imported Date: 8/11/2021

EN Revision Text: AGREEMENT STATE REPORT - MEDICAL UNDERDOSE EXCEEDING 20 PERCENT

The following information was obtained from the Illinois Emergency Management Agency (the Agency) via email:

"Loyola University Medical Center (IL-01131-02), contacted the Agency on August 3, 2021, to advise that an administration of Y-90 resulted in an underdose exceeding 20 percent. The incident occurred yesterday, August 2, 2021. No untoward medical impact was expected to the patient.

"The licensee's Radiation Safety Officer contacted [the Agency] to advise that a patient scheduled to receive Y-90 microsphere therapy (Theraspheres) for hepatocellular cancer on August 2, 2021 received only 71 percent of the dose prescribed in the written directive. The licensee's Radiation Safety Officer is reviewing the device today as well as the specifics of the administration to determine root cause. The licensee suspects a problem with a connector but is currently investigating. No personnel or area contamination was reported. It remains to be determined if the dose delivered was clinically effective or if an additional treatment is planned. It is unclear at this point if the referring physician or the patient has been notified. An update has been requested within one hour and Agency staff noted the 24 hour notification requirement. Agency inspectors will perform a reactionary inspection, tentatively within a week, to assist in determining root cause and gather the additional information required. This matter is reportable under 32 Ill. Adm. Code 335.1080(a)(1)(B). A written report will be required of the licensee within 15 days."

Illinois NMED report number: IL210023

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.