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| Start date | Reporting criterion | Title | Event description | System | LER | |
|---|---|---|---|---|---|---|
| ENS 52709 | 25 April 2017 04:00:00 | Agreement State | Agreement State Report - Medical Event Due to Underdose of Yittrium-90 Theraspheres | The following information was obtained from the Commonwealth of Pennsylvania via fax: Event Description: The event involved a patient who was scheduled to be treated with 11.87 mCi of Y-90 microspheres (TheraSphere), but only received an estimated 5.07 mCi, or 43% of the prescribed dose. The licensee reported the event to the Department (Pennsylvania Department of Environmental Protection) on April 25, 2017. Initial indication is that there was a faulty connection on the catheter line that allowed a leak to occur. The patient and referring physician were notified the day of the procedure. No Jefferson personnel skin contamination occurred. However, gloves, drapes and the patient's skin were contaminated. The patient was quickly decontaminated with alcohol wipes. All remaining areas were also decontaminated. A skin calculation is currently being completed by the licensee to determine the patient's exposure, if any. No overexposure is believed to have occurred. Cause of the Event: Unknown at this time. Suspected human error. Actions: The Department will perform a reactive inspection. The licensee will update their procedure to include additional checks of the Y-90 administration kit. More information will be provided upon receipt. PA Event Report ID No.: PA170009 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 52093 | 13 July 2016 04:00:00 | Agreement State | Agreement State Report - Underdose Medical Event | The following was received via email: Event Description: A patient was undergoing a Y-90 Therasphere procedure in two separate treatments (to different liver segments). The delivery kits for both administrations passed the standard pre-administration testing. The physician and team noted no other equipment related issues until the administering Interventional Radiologist Physician noted unusual resistance during the first actual administration. After unsuccessful attempts to 'clear the line,' the efforts to complete the administration were terminated. The team then attempted to treat a second site, with essentially the same sequence of events occurring. Both delivery sets came from the same manufacturing lot, and both dosages of Theraspheres came from the same drug lot. The licensee estimates approximately 25 percent of the written directive dose was delivered. Cause of the Event: Unknown at this time. It is worth noting, another Theraspheres administration on another patient was performed the following day without incident. The delivery system kits were again from the same lot as those used on the previous day, but the Therasphere dosage was from a different lot. Actions: Licensee notified Nordion of the occurrence. The Department (PA Department of Environmental Protection) will perform a reactive inspection next week. Event Report ID: PA160019 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 47771 | 22 March 2012 04:00:00 | Agreement State | Agreement State Report - Patient Received Less than Intended Dose | The following information was received via facsimile: On March 23, 2012 the Southeast Regional Office (of the Pennsylvania Department of Environmental Protection - Bureau of Radiation Protection (Department)) received notice from the hospital of a medical event involving yittrium-90 TheraSpheres. The patient was being treated for disease of the liver and received 76% of the intended dose in the first delivery and 56% of the intended dose in the second delivery. The cause of the event is currently under investigation. More information will be provided when received. No harm to the patient is expected. The oncologist was satisfied with the treatment and no additional delivery is anticipated. The Department will conduct a reactive inspection. Pennsylvania Event Report ID No: PA120010 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 47612 | 20 January 2012 19:09:00 | Agreement State | Agreement State Report - Misadministration of Dose to Patient | The following information was provided by the Commonwealth of Pennsylvania via facsimile: On January 20, 2012, at 1409 EST, the Department's (PA Bureau of Radiation Protection) southeast regional office received notification via phone call about this ME (Medical Event). On January 19, 2012, a worksheet was prepared for two patients who were to be treated on the same day, close in time. The worksheets were switched and each patient received the other patient's dose. The first patient reached stasis before receiving the full amount and received a dose 35% above the planned dose. The second patient received 55% less than what was planned. CAUSE OF THE EVENT: Human error. ACTIONS: No adverse effects are expected from the overdose to the first patient. The second patient will receive a higher dose than planned at their next schedule treatment. The licensee plans on modifying their current procedures to prevent this event from occurring again. The Department plans to do a reactive inspection. Event Report 10 No: PA120005 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 47281 | 16 September 2011 18:14:00 | Agreement State | Agreement State Report - Medical Event Involving Y-90 Therasphere Underdose | The following information was received from the Commonwealth of Pennsylvania via facsimile: Event Type: A medical event (ME) involving Y-90 Theraspheres where the patient received 51% of the intended dose, which is reportable under 10CFR35.3045(a)(1)(ii). 'Notifications: On September 16, 2011, at 1414 (EDT), the Department's Southeast Regional Office received notification via phone message about the ME. Event Description. The patient was being treated with MDS Nordion Y-90 glass Theraspheres for transarterial radioembolization. A suspected defective catheter caused 49% of the intended dose to clog up in the catheter. No harm to the patient is expected. The referring physician and patient have been notified. No more information is available at this time. Cause of the event: The cause of the event is suspected to be a defective catheter. Actions: After decay, the catheter will be returned to Nordion for inspection and may also be returned to the manufacturer, Terumo Medical, for a defect analysis. The licensee will be submitting a written report within 15 days. The (Pennsylvania) Department (of Environmental Protection) plans to do a reactive inspection. PA Report ID: PA110025 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. |