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| Start date | Reporting criterion | Title | Event description | System | LER | |
|---|---|---|---|---|---|---|
| ENS 56777 | 4 October 2023 06:00:00 | Agreement State | Medical Underdose | The following information was provided by the Colorado Department of Public Health and Environment (the Agency) via email: On October 4, 2023, the radiation safety officer of the University of Colorado Hospital reported a medical event to the emergency response line. The medical event occurred during the administration of a Y-90 TheraSphere treatment that took place that day. The authorized user stated that high back pressure was observed during administration so only 71.2 percent of the prescribed dose was delivered to the treatment area. This is the third medical event (May 18, 2023 - CO230012 and May 24, 2023 - CO230014) with Y-90 TheraSpheres at this facility in the last six months. Different authorized users and IR (Interventional Radiology) technologists were present at each medical event. The Agency is currently waiting for additional information from the hospital and the Agency intends to follow up with an in-person investigation. Event Report ID No.: CO2300034 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 56540 | 24 May 2023 19:00:00 | Agreement State | Patient Underdose | The following information was provided by the Colorado Department of Health via email: On May 24, 2023, the Radiation Safety Officer of the University of Colorado Hospital (RAML (Radioactive Material License) 828-01) reported a medical event. The medical event occurred during the administration of Y-90 TheraSphere treatment that took place in the afternoon on Wednesday, May 24, 2023. During the administration, there appeared to be an obstruction in the catheter's line preventing the target from receiving the intended dose. The obstruction was noticed early in the procedure and it's estimated only 5 to10 percent of dose went to the target organ. After the obstruction was observed, the catheter was removed from the patient and the rest of the dose was not administered. This event is similar to an event at the same hospital on May 18, 2023 (CO230012) which occurred with a different AU (authorized user). The TheraSpheres were from the same batch. The licensee is pausing Therasphere administrations from the same lot number. We are still waiting on additional information from the hospital about the investigation. Event Report ID No.: CO230014 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 56529 | 18 May 2023 06:00:00 | Agreement State | Medical Event (Patient Underdose) | The following was received from the Colorado Department of Public Health and Environment via email: On May 19, 2023, the associate radiation safety officer at the University of Colorado Hospital reported a medical event. The event occurred on May 18, 2023, during a Y-90 TheraSphere administration. The licensee reported that during the administration, there was an obstruction in a line/catheter causing the target to only receive 4.6 percent of the intended dose. The authorized user does not believe the obstruction was due to stasis. The prescribed dose for the treatment was 300 Gy (20.06 mCi) and the administered dose was calculated to be 13.87 Gy (0.93 mCi). The licensee is working with the manufacturer, and the exact cause of the obstruction resulting in the medical event is still under investigation. Colorado Event Report Number: CO230012 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 55111 | 22 February 2021 19:30:00 | Agreement State | Lutetium-177 in Stolen Vehicle Recovered | The State of Colorado, Radioactive Materials Unit reported the following via email: On February 22, 2021, at approximately 1230 (MST), the Colorado Department of Public Health and Environment (CDPHE) was notified that a shipment of lutetium-177 dotatate was involved in a stolen vehicle incident. The incident occurred during a shipment via courier to the University of Colorado Hospital, CO 828-01; the shipment originator is Advanced Accelerator Applications. The courier's vehicle was recovered by the Aurora Police Department and the vial of lutetium-177 dotatate was found on the driver's seat of the vehicle and had been removed from the shipping container. The University of Colorado Hospital will be taking possession of the material. Isotope: lutetium-177. Activity: 200 mCi. Aurora Police Case Number: 2021-7342. The situation is currently unfolding and more information will be available at a later date. Colorado Event Report ID No: Unassigned. Sources that are "Less than IAEA Category 3 sources," are either sources that are very unlikely to cause permanent injury to individuals or contain a very small amount of radioactive material that would not cause any permanent injury. Some of these sources, such as moisture density gauges or thickness gauges that are Category 4, the amount of unshielded radioactive material, if not safely managed or securely protected, could possibly - although it is unlikely - temporarily injure someone who handled it or were otherwise in contact with it, or who were close to it for a period of many weeks. For additional information go to http://www-pub.iaea.org/MTCD/publications/PDF/Pub1227_web.pdf | ||
| ENS 54193 | 1 August 2019 21:30:00 | Agreement State | Agreement State Report - Possible Lost Radioactive Material | The following was received from the Colorado Department of Public Health and Environment (CDPHE) via e-mail: The licensee reported at approximately 1530 hrs. (MDT) of August 1, 2019 to CDPHE that there was a package in the morning of August 1, 2019, with its shipping paper indicating two vials of Lu-177 (200 mCi). The licensee only has 1 vial in possession and the nuclear medicine technician who opened the package did not remember seeing two vials in the package. The package has been disposed of in the hospital dumpster before the licensee identified this. The licensee surveyed the dumpster but did not identify any source of Lu-177. The licensee contacted the vendor and is awaiting more information from the vendor regarding whether a second vial was ever shipped from the vendor to the licensee." Colorado Event Report No: CO190015 THIS MATERIAL EVENT CONTAINS A "LESS THAN CAT 3" LEVEL OF RADIOACTIVE MATERIAL Sources that are "Less than IAEA Category 3 sources," are either sources that are very unlikely to cause permanent injury to individuals or contain a very small amount of radioactive material that would not cause any permanent injury. Some of these sources, such as moisture density gauges or thickness gauges that are Category 4, the amount of unshielded radioactive material, if not safely managed or securely protected, could possibly - although it is unlikely - temporarily injure someone who handled it or were otherwise in contact with it, or who were close to it for a period of many weeks. For additional information go to http://www-pub.iaea.org/MTCD/publications/PDF/Pub1227_web.pdf | ||
| ENS 52851 | 12 July 2017 17:00:00 | Agreement State | Agreement State Report - Misadministration of Treatment | The following information was received from the State of Colorado via email: This is an initial report regarding a misadministration event in Colorado. University of Colorado Hospital (License Number: CO 828-01) had a misadministration of Y-90 microspheres (SIRTex SIRSpheres) on Wednesday, July 12, 2017. At approximately 11 (MDT), the post administration measurements of the waste from the SIRSpheres Administration indicated that the activity administered to segment 2/3 of the patient's liver was only 68.7 percent of the prescribed activity. The written directive called for an activity of 0.24 GBq and residual waste activity measurements indicated that 0.165 GBq was delivered. The physician indicated that stasis was not reached during the administration to this segment. There was a separate administration to segment (four) of the liver in which stasis was reached. Follow-up information will be provided after they are available. 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 51470 | 14 October 2015 20:30:00 | Agreement State | Colorado Agreement State Report - Patient Received 40 Percent Less than Prescribed Dose | The following information was provided by the State of Colorado via email: The (licensee) RSO reported that a patient received 40 percent less than the prescribed dose during a TheraSphere (Y-90) treatment on 10/14/2015. The exact cause is still under investigation. Initial written direction was for 120 Gy. However, due to unavailability of this dose the written directive was amended to 140 Gy and the dose was ordered. The AU (Authorized User) reported that stasis was not reached and it was believed the patient received the entire dose. The associated survey meter was reading 0 and the AU flushed the system 3 times - the meter continued to read 0. The procedure ended around 1430 MDT. After the procedure the AMP (Authorized Medical Physicist) reviewed the paperwork, took waste measurements and performed calculations. At this point 40 Gy was found in the waste. The RSO was notified at 1545 MDT. At this time, it is not known if the patient has been notified. 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 47043 | 8 July 2011 13:30:00 | Agreement State | Agreement State Report - Medical Event Overexposure to Thyroid Gland | The following was received from the state via fax: The Colorado Department of Public Health and Environment received notification this date from The University of Colorado Hospital, Colorado License # 828-01, that a patient received the wrong dose of I-131 on July 8, 2011 resulting in a dose that exceeded prescribed by 50 rem and 50% of the dose expected from the administration defined in the written directive. The patient was prescribed 20 mCi of l-131 for Graves disease, but instead received 100 mCi of I-l31, which was intended for another patient. The patient was discharged before the error was discovered. The patient's physician and the patient have been contacted and made aware of the situation. The patient has been given additional instructions regarding contact with family members and members of the public. No other details are available at this time. The Colorado Department of Public Health and Environment has initiated an investigation. 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. |