Semantic search
| Start date | Reporting criterion | Title | Event description | System | LER | |
|---|---|---|---|---|---|---|
| ENS 56319 | 11 January 2023 05:00:00 | Agreement State | Patient Underdose | The following information was provided by the Pennsylvania Department of Environmental Protection, Bureau of Radiation Protection (the Department) via email: On January 20, 2023 the licensee informed the Department of an under-dose incident involving yttrium-90 (Y-90) TheraSpheres. It is reportable per 10 CFR 35.3045(a)(1). On January 11, 2023 an Authorized User (AU) in Interventional Radiology was attempting to treat a patient with 45.4 mCi of yttrium-90 TheraSphere. The AU could not get the spheres to infuse. After consultation with the manufacturer (Boston Scientific), they decided on aborting the procedure. It was determined the patient received zero activity and all the radioactivity from the spheres remained inside the treatment vial. The patient and referring physician have been informed. The Department is currently in contact with the licensee and will update this event as soon as more information is provided. Event Report ID No: PA230005 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 55376 | 22 July 2021 04:00:00 | Agreement State | Patient Under Dose | The following was received via an email from the Pennsylvania Department of Environmental Protection (DEP) via email: On July 22, 2021 a patient was receiving a Lutetium-177 (Lutathera) treatment when technicians had difficulty establishing an IV injection site and flow. Several attempts were made, but ultimately they all failed. The prescribed dose was 200 milliCuries, but it is estimated that the patient received only 18 millicuries. No adverse effects to the patient are noted at this time and none are expected. The patient and prescribing physician have been informed. Preliminary cause is suspected to be poor venous access for patient as well as incorrect gauge needle used for patient access. The DEP will update this event as soon as more information is provided. The Department will perform a reactive inspection. Pennsylvania Event Report ID No: PA210008 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 53073 | 15 November 2017 05:00:00 | Agreement State | Agreement State Report - Incorrect Written Directive for Liver Patient | The following report was received from the Pennsylvania Bureau of Radiation Protection via facsimile: The event involved a patient who was scheduled to be treated with 16 mCi of Y-90 SirSpheres to the left lobe of the liver. The written directive (WD), however, was incorrectly written for the right lobe of the liver. The authorized user (AU) did in fact deliver the correct dose to the correct lobe and the discrepancy was only noticed after the procedure was complete. No harm is expected as the patient received the intended dose to the correct location. The cause of the event was noted as human error resulting from: (1) Failure of the AU to indicate the correct treatment site on the WD. (2) Failure of the AU to forward documentation of the pre-therapy information to the RSO (or designee) prior to the therapy. (3) Failure of clinical staff to identify the discrepancy on the WD during the patient time out just before implantation of the microspheres. Corrective actions include: Before drawing up the dose/activity in Nuclear Medicine (and preferably before the dose/activity is ordered from the manufacturer), the AU must forward pre-therapy documentation (WD, pre-post therapy worksheet, etc.) to the RSO (or designee) to ensure documentation is correct/appropriate. The Department (Pennsylvania Bureau of Radiation Protection) will perform a reactive inspection. The licensee will update their procedure to include additional checks for the written directive. Event Report ID No: PA 170016 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 51590 | 4 December 2015 05:00:00 | Agreement State | Agreement State Report - Delivered Dose of Yttrium-90 Less than Prescribed Dose | The following report was received from the Pennsylvania Department of Environmental Protection via facsimile: On 12/4/2015, a patient was scheduled for a yttrium-90 (Y-90) Sirsphere procedure. The prescribed dose on the written directive was 10 mCi. The ion chamber measurements indicated a delivered dose of 7.72 mCi (-22.8% of prescribed dose). Both the patient and referring physician were notified. No harm is expected to the patient. A reactive inspection is planned by the Pennsylvania Department of Environmental Protection. Pennsylvania Event Report ID No: PA150032 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. |