ENS 53879
ENS Event | |
|---|---|
13:24 Feb 13, 2019 | |
| Title | En Revision Imported Date 6/5/2019 |
| Event Description | 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. |
| Where | |
|---|---|
| University Of Arkansas For Medical Sciences Little Rock, Arkansas (NRC Region 4) | |
| License number: | ARK-0001-02110 |
| Organization: | Arkansas Department Of Health |
| Reporting | |
| Agreement State | |
| Time - Person (Reporting Time:+51.72 h2.155 days <br />0.308 weeks <br />0.0708 months <br />) | |
| Opened: | Angie Hill 17:07 Feb 15, 2019 |
| NRC Officer: | Thomas Kendzia |
| Last Updated: | Jun 4, 2019 |
| 53879 - NRC Website | |
University Of Arkansas For Medical Sciences with Agreement State | |
WEEKMONTHYEARENS 571782024-06-07T05:00:0007 June 2024 05:00:00
[Table view]Agreement State Y-90 Microsphere Underdose ENS 538792019-02-13T13:24:00013 February 2019 13:24:00 Agreement State En Revision Imported Date 6/5/2019 ENS 511302015-06-04T05:00:0004 June 2015 05:00:00 Agreement State Agreement State Report - Medical Treatment Incorrect Dose ENS 467182011-03-16T05:00:00016 March 2011 05:00:00 Agreement State Agreement State Report - Yttrium-90 Microspsheres Administered Dose Less than Prescribed Dose 2024-06-07T05:00:00 | |