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| Start date | Reporting criterion | Title | Event description | System | LER | |
|---|---|---|---|---|---|---|
| ENS 55406 | 13 August 2021 05:00:00 | Agreement State | Medical Event | The following information was obtained from the Illinois Emergency Management Agency (the Agency) via email: Loyola University Medical Center contacted the Agency this afternoon to report a medical underdose of Lu-177 that occurred today, August 13, 2021. Although information provided was preliminary, no untoward medical impact is expected to the patient. (The) Radiation Safety Officer for the licensee contacted the Agency at approximately 1500 CDT on August 13, 2021, to report that a patient scheduled to receive 200 mCi of Lu-177, Lutathera therapy for neuroendocrine tumors, received only 14 percent of the dose prescribed (28 mCi) in the written directive. The underdosing was intentionally aborted by the authorized user after the patient advised they had received the planned chemotherapy injection the day before, rather than after the radiopharmaceutical administration per procedure. The licensee is investigating root cause. The licensee is calculating organ dose to the kidney, but preliminary estimates are 67 rad. If the dose falls beneath 50 rad, the incident may be retracted. Notification to the patient and the referring physician has been completed. Agency inspectors are awaiting additional information but plan a reactive inspection within 10 days. The reporting requirements for the licensee, as specified in 32 Ill. Adm. Code 335.1080(c) were met, and the licensee is aware of the need for a written report within 15 days. This report will be updated as additional information becomes available. Illinois NMED Report No.: IL210024 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 55393 | 2 August 2021 05:00:00 | Agreement State | 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. | ||
| ENS 55199 | 19 April 2021 05:00:00 | Agreement State | Medical Event | The following was received from the Illinois Emergency Management Agency (the Agency) via email: (The licensee) contacted the Agency this afternoon to report a medical underdose of Y-90 that occurred today, April 19, 2021. Although information provided was preliminary, no untoward medical impact is expected to the patient. (The) Radiation Safety Officer for the licensee contacted the Agency at 1515 CDT on April 19, 2021, to report a patient scheduled to receive Y-90 microsphere therapy (Theraspheres) for hepatocellular cancer received only 63 percent of the dose prescribed in the written directive. The Agency understands this to be one of three fractions delivered. Additional data is forthcoming. Reportedly, the underdosing was due to a leakage of Y-90 microspheres in the connection between the Therasphere tubing and the microcatheter. The leakage resulted in area and personnel contamination which was promptly and successfully addressed by on-site radiation safety staff. No skin doses are reported or anticipated. (The Agency) will dispatch staff to the site tomorrow for a reactionary inspection. 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 49484 | 29 October 2013 05:00:00 | Agreement State | Administration of Less than the Prescribed Dose to a Patient | The following report was received from the Illinois Emergency Management Agency via e-mail: On October 29, 2013, the RSO at Loyola University Medical Center (IL-01131-02) called to report a medical event which occurred at their facility the previous day. A treatment dose of 115 Gray (10.5 mCi) of Nordion's Y-90 Theraspheres was prescribed. However, at the completion of the treatment and in accordance with manufacturer's use instructions, the system was evaluated for residual material. Elevated levels were detected within the combination of the catheter, tubing and source delivery vial apparatus. Those elevated levels were determined to correspond to over 2 mCi of Y-90. A detailed evaluation revealed 8.04 mCi had been administered for a total delivered dose of 88 Gray or 76.5% of the intended dose. Most of the remaining 2.5 mCi of Y-90 was adhered within the catheter about 1 inch from the catheter/tubing interface connector despite successfully completing the treatment in less than a minute including 3 successful flushes of the system with 30 cc of sterile solution. No material was detected as remaining in the source vial which was monitored closely during the treatment with a dedicated dosimeter nor were there any observable defects in the catheter or manufacturer supplied tubing where the microspheres had accumulated. As per regulations, the patient was advised of the situation by the interventional radiologist. Neither the physician authorized user, an oncologist, nor the interventional radiologist believes that there will be any adverse impact to the patient as a result of the lowered dosage. There are no plans to supplement/repeat this treatment to deliver any remaining/additional amount of radiation nor does the licensee have any immediate corrective actions to implement in that the procedure already follows the manufacturer's recommendations. The licensee is aware of the requirement to submit a written report within 15 days. The cause of this event was equipment failure. Illinois Item Number: IL13032 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 49333 | 7 September 2013 05:00:00 | Agreement State | Agreement State Report - Radiopharmaceutical Package Had External Contamination | The following information was obtained from the State of Illinois via email: Saturday morning a call was received by the Illinois Emergency Management Agency (IEMA) from the RSO at Loyola University Medical Center reporting exterior contamination on one of two packages received from their radiopharmacy, Cardinal Health, that same morning. Staff at Loyola confirmed the presence of contamination with a second wipe which measured less than 15,000 dpm. The contaminant was verified as Tc-99m by Loyola staff. The package involved contained 6 doses of Tc-99m to be used for imaging that morning. Smears taken of the interior of the package and on each shielded syringe showed no removable contamination present. Smears on the exterior of the black nylon shipping package showed contamination only on the bottom of the package and on no other surfaces. The maximum measured dose rate from the empty package near the surface of the contaminated package was less than 500 microRem/h. The second package which had arrived at the same time as the first showed no contamination or unexpected radiation levels. The pharmacist at Cardinal Health was subsequently contacted by the Agency (IEMA) that same morning. The responsible pharmacist confirmed he'd been notified by the RSO of Loyola University Medical Center immediately at the time of discovery of the event. The pharmacy's courier vehicle made one other delivery to an area hospital before reaching Loyola and then proceeded to a third hospital. Both other facilities were contacted by Cardinal and told to be on the lookout for potential exterior contamination should cross contamination be involved. The pharmacist indicated that neither facility reported any noted contamination. The pharmacist noted that the couriers for all packages from their facility in Glendale Heights are Cardinal employees using Cardinal vehicles. Once the vehicle returned to Glendale Heights, surveys of the vehicle were completed and no removable contamination or elevated levels were detected. During the interim, a survey of the radiopharmacy was also conducted with no contamination found in the package preparation areas. Based on this information and past inspection results of both facilities, it appears this event is an isolated instance where incomplete/inadequate surveys were conducted to evaluate the potential hazard present and assure that packages offered for transport are free of contamination in excess of the limits. Illinois Item Number: IL13026 |