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| Start date | Reporting criterion | Title | Event description | System | LER | |
|---|---|---|---|---|---|---|
| ENS 57178 | 7 June 2024 05:00:00 | Agreement State | Y-90 Microsphere Underdose | The following information was provided by the Arkansas Department of Health, Radiation Control, Radioactive Materials Program (the Agency) via email: The Agency was notified by the Radiation Safety Officer (RSO) for the University of Arkansas for Medical Sciences on Friday afternoon, June 7, 2024, to advise of a possible Y-90 TheraSphere misadministration where the patient did not receive all the prescribed dose. The administration was two doses to segment 5 of the patient's liver. The discovery was made when the tubing and waste from the procedure was surveyed after it was returned to the lab. The written report was received on Friday afternoon, June 14, 2024. On June 17, 2024, the Agency reviewed the information provided and determined that this event is a misadministration due to the following: The administered doses both differed from their respective prescribed doses by more than 0.5 Sv (50 rem) to an organ. The delivered dose of 95 Gy (9500 rem) was 198 Gy (19800 rem) less than the (prescribed) dose of 293 Gy (29300 rem) for dose number one; the delivered dose of 105 Gy (10500 rem) was 21 Gy (2100 rem) less than the (prescribed) dose of 126 Gy (12600 rem) for dose number two. (For) dose number one only, the total dose delivered differs from the prescribed dose by twenty percent or more. Dose number one was outside the treatment prescription range; 68 percent of the prescribed dose was not received. Therefore, (dose) number one is considered to be a misadministration in accordance with current emerging medical technology licensing guidance. Dose number two was just inside the treatment prescription range; 17 percent of the prescribed dose was not received. The referring physician and (the) patient were notified, and the patient has been scheduled for an additional treatment. The investigation is ongoing, and reporting will proceed in accordance with SA-300. Arkansas Event number: AR-2024-004 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 53879 | 13 February 2019 13:24:00 | Agreement State | En Revision Imported Date 6/5/2019 | EN Revision Text: AGREEMENT STATE REPORT - DOSE DELIVERED WAS LESS THAN PRESCRIBED The following was received from the Arkansas Department of Health, Radiation Control Program (the Department) via email: The treatment prescribed activity was for 0.54 GBq (14.5 mCi) on February 13, 2019. The calibrated activity at projected treatment time was 0.53 GBq (14.3 mCi). The patient received a dose of 0.204 GBq (5.51 mCi) due to 61.5 percent of the dose remaining in the connector of the manufacturer tubing and the catheter Terumo-Progreat Microcatheter (2.0 French Catheter). The Department performed an on-site review and investigation on February 15, 2019 at approximately 1215 (CST). The Department performed exposure surveys of the connector confirming activity stuck at the connector site. The connector site read the highest and in that concentrated area, reading 430 mR/hr, on February 15, 2019, at approximately 1415 (CST). There were no spills and/or contamination during this event. The licensee notified the manufacturer and the manufacturer will be performing an investigation on the tubing and radiopharmaceutical/sealed sources. The licensee is continuing to investigate the root cause and is preparing an initial fifteen day written report. The Department is waiting on information from the manufacturer(s) and licensee for further investigation. The Department will update this report when the licensee provides additional information. Arkansas Event AR-2019-001
The following update was received from the Arkansas Department of Health, Radioactive Materials Program via email: The Department (Arkansas Department of Health) received a Y-90 TheraSphere Glass Microsphere patient therapy misadministration notification on February 14, 2019 from a medical licensee. The Department performed an on-site review and investigation on February 15, 2019 at approximately 1215 (CST). The Department has received the required initial fifteen day report from the Licensee. The Y-90 TheraSphere therapy prescribed activity was for 0.54 GBq (14.6 mCi) on February 13, 2019. The Y-90 TheraSphere calibrated activity at projected treatment time was 0.53 GBq (14.3 mCi). The patient received a dose of 0.204 GBq (5.51 mCi) due to 61.5 percent of the dose remaining in the connector of the manufacturer tubing and the catheter. The catheter used was a Terumo-Progreat Microcatheter (2.0 French Catheter). This dose resulted in a 54.34 Gy exposure instead of the intended 143 Gy exposure. The Licensee performs Y-90 TheraSphere therapies on a regular basis. The Licensee's physician/Authorized User and colleagues state that they have never had this issue before. The Authorized User states that 54.34 Gy is still a therapeutic dose. A patient CT follow-up scan will be performed to evaluate the therapy dose effectiveness. The Department verified activity stuck at the connector site via exposure surveys with a Fluke ion chamber survey meter (reading 430 mR/hr) on February 15, 2019 at approximately 1415 (CST). The Licensee notified the Manufacturer and the Manufacturer will be performing an investigation on the tubing and on the radioactive sealed sources. There were no spills and/or contamination during this event. The Department is waiting on information from the Licensee regarding the Manufacturer's investigation. The Department will update this report when the Licensee provides additional information. Corrective Actions: In Process by Licensee and Manufacturer. Notified the R4DO (Werner), NMSS Events (via email).
The Department received a report on April 24, 2019 (dated April 4, 2019) from the Licensee regarding the Y-90 TheraSphere misadministration. The Department requested additional information on April 24, 2019, regarding the information provided by the Licensee. The request includes clarification from the manufacturer's report and the Licensee's corrective actions. The Department will update this report when the Licensee provides additional information. Notified R4DO (Young) and NMSS Events (via email).
The following information was obtained from the state of Arkansas via email: The Licensee has submitted to the Department the Manufacturer's Report, possible Root Cause and Corrective Actions. According to the Manufacturer's Report, it states 'the most likely cause of this event is insufficient flow rate due to high backpressure associated with the microcatheter.' 'BTG (the manufacturer) recommends following the TheraSphere package insert guidance for the selection of a microcatheter with an inner diameter that is equal or larger than 0.020 inch.' The Manufacturer's Report also states, in part, 'A review of the manufacturing records confirmed there were no device defects.' It is noted by the Licensee that the Authorized User prescribed a different size microcatheter from the Manufacturer Recommendations and Manufacturer's package insert. The Licensee states regarding the root cause, 'After testing the tubing and catheter, it was determined that the event was caused by insufficient flow through the microcatheter possibly caused by overall length and inner diameter of the microcatheter, septum fragments from the dose vial, and possible changes in the condition of materials during the time from treatment to inspection (e.g. dried saline, coiled in tight bends for extended time.' 'Having several potential causes and contributing factors, the root cause is still not known.' The Licensee states that their corrective actions to prevent reoccurrence are '(1) continue to abide by our standard operating procedure of performing three flushes, ensuring the electronic dosimeter, or rados, is reading zero, and surveying the patient; (2) Flush an additional time with 20 mL of saline after the rados reads zero; (3) Will use a catheter with a diameter greater than or equal to 0.02 inches. A smaller catheter will only be used if the patient would otherwise be unable to receive the treatment due to small vessels.' The Department did not issue any Items of Noncompliance for this medical event. The Department considers this event closed. Notified R4DO (Kellar) and NMSS Events Notification (email). 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 51130 | 4 June 2015 05:00:00 | Agreement State | Agreement State Report - Medical Treatment Incorrect Dose | The following was received via email: On June 5, 2015, the Arkansas Department of Health (ADH) received notification from the licensee's Radiation Safety Officer (RSO) of a possible medical event that occurred during an Yttrium-90 TheraSpheres procedure on June 4, 2015. The licensee has not completed the investigation and has provided limited information to determine if the procedure constituted a medical event. The patient was treated with Y-90 TheraSpheres. The written directive prescribed a dose of 114 Gy, but received a dose of 18.3 Gy. Preliminary findings seem to indicate that an incorrect dose may have been administered to the patient. The patient and referring physician have been notified. The licensee and ADH are continuing to investigate this event. ADH considers this event to be opened and will provide more information as it becomes 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. ARKANSAS EVENT #2015-005
The following information was received from the State of Arkansas via email: The Arkansas Department of Health (ADH) is requesting the retraction of NRC Event Number (51130). ADH received a report from the licensee dated June 18, 2015. The report and investigation conducted by the licensee determined that this event did not qualify as a reportable medical event. A review of the written directive indicated that the radiation dose that was prescribed by the authorized user was delivered to the patient. The authorized user had intended to prescribe 114 Gray. This was confirmed by ADH after further review of the documentation obtained during the on-site investigation. The patient completed this treatment on June 29, 2015. The licensee has implemented revisions in the treatment procedures for further safety improvements. The ADH considers this event to be closed. Notified the R4DO (Haire) and NMSS Events Notification Group via email. | ||
| ENS 46718 | 16 March 2011 05:00:00 | Agreement State | Agreement State Report - Yttrium-90 Microspsheres Administered Dose Less than Prescribed Dose | The following was received from the State of Arkansas via email: On March 16, 2011, a patient was scheduled for two administrations of Y-90 microspheres. The first dose administration was conducted without incident. As the second dose was being delivered, the syringe plunger was accidentally rotated so that the stopper inside the syringe was engaged momentarily causing a pause in administration. Due to the pause, the microspheres in the catheter at the time of the pause settled in the catheter and were not administered to the patient. The facility has contacted the manufacturer of the administration device. On the morning of March 17, 2011, Interventional Radiology informed the referring physician, and patient of the event. Conditions requiring reporting of this event: The dose differs from the prescribed dose by more than 50 Rem to an organ The delivered dose of 69.56 Gy was 24.44 Gy (2444 rads) less than the optimal dose of 94 Gy and 10.44 Gy (1044 rads) less than the minimal dose in the prescription range. And the total dose delivered differs from the prescribed dose by twenty percent (20%) or more. The total dose delivered, 69.56 Gy, differed by twenty-six percent (26%) from the optimal dose of 94 Gy and was outside the treatment prescription range of 80-150 Gy. Arkansas Event Number: 03-11-03 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.
Corrective actions concerning the TheraSphere medical event were submitted to the Arkansas Department of Health. The University of Arkansas for Medical Sciences (UAMS) now requires that all Interventional Radiology staff and residents who will participate in the injection of Y-90 TheraSpheres will receive training on the injection technique prior to administering the radioisotope. The staff will practice the injection process by using normal saline. The staff has also been instructed to administer the dose in a continuous manner without pause. Lastly, the catheter tubing was previously being flushed three times, as recommended by the manufacturer, but the tubing will now be flushed at least five times. The Arkansas Department of Health considers this incident to be closed. Notified R4DO (Proulx) and FSME EO (McIntosh). |