EN Revision Imported Date : 4/25/2019
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
* * * UPDATE AT 1516 EST ON 3/7/19 FROM ANGIE HALL TO JEFF HERRERA * * *
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).
* * * UPDATE FROM ANGIE HALL TO HOWIE CROUCH VIA EMAIL ON 4/24/19 AT 1708 EDT * * *
"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).
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. |