ENS 54641
ENS Event | |
|---|---|
04:00 Apr 3, 2020 | |
| Title | Agreement State Report - Patient Underdose |
| Event Description | The following was received from the State of Pennsylvania via E-mail:
The [PA DEP Bureau of Radiation Protection] Department received notification from a licensee on April 3, 2020 of a medical event involving Y-90 TheraSphere microspheres. The licensee believes a patient undergoing a multiple lobe injection of the liver received only 62.7 percent of the prescribed dose in one of the lobes. The second lobe is believed to have received the correct dose. The DEP is currently in contact with the licensee and will update this event as soon as more information is provided. The Department will perform a reactive inspection as soon as possible. Pennsylvania Event Report ID No.: PA200007
The following was received from the State of Pennsylvania via E-mail: The patient was prescribed TheraSphere Y-90 Microspheres at 2.47 GBq total with 2.25 Gbq prescribed to the liver because of 9.1 percent lung shunt. The licensee reports total dose 1.536 GBq, and 1.4 GBq to liver. Ultimately only 62.7 percent (75.3 Gy) of the planned dose was able to be administered to segment 6 of the liver. While attempting to administer the Y-90 dose to treat a lesion in Segment 6 of the liver there was significant resistance to flow. The AU evaluated the microcatheter system to ensure that there were no kinks along the catheter course external to the patient or visualized internally under fluoroscopy. The licensee believes the issue came from blockage at or before the 'E' site on the labeled tubing of the administration set, given that when it was disconnected from the microcatheter at that location, they were able to successfully flush the catheter. The patient then had a subsequent segment 7 segmentectomy using tubing from a box set from a different lot number without incident. No adverse effects to the patient are anticipated and the patient and referring physician were notified the day of the event. Notified R1DO (Lilliendahl) and NMSS Events Notification 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. |
| Where | |
|---|---|
| Pa Bureau Of Radiation Protection Philadelphia, Pennsylvania (NRC Region 1) | |
| License number: | PA-0135 |
| Organization: | Pa Bureau Of Radiation Protection |
| Reporting | |
| Agreement State | |
| Time - Person (Reporting Time:+82.15 h3.423 days <br />0.489 weeks <br />0.113 months <br />) | |
| Opened: | John Chippo 14:09 Apr 6, 2020 |
| NRC Officer: | Kerby Scales |
| Last Updated: | Apr 7, 2020 |
| 54641 - NRC Website | |
Pennsylvania Bureau of Radiation Protection with Agreement State | |||
| Agreement State Report - Recovered Miscellaneous Radioactive Items ENS 549112020-08-24T04:00:00024 August 2020 04:00:00 Agreement State | Agreement State Report - Stuck Shutter ENS 548352020-08-11T04:00:00011 August 2020 04:00:00 Agreement State Agreement State Report - Patient Underdose ENS 547052020-05-11T04:00:00011 May 2020 04:00:00 Agreement State Agreement State Report - Radiation Level on Package Exceeds Dot Limits ENS 546962020-05-05T04:00:0005 May 2020 04:00:00 Agreement State Agreement State Report - Medical Event ENS 546792020-04-05T04:00:0005 April 2020 04:00:00 Agreement State Agreement State Report - Stuck Shutter on Berthold Radioactive Gauge ENS 546412020-04-03T04:00:0003 April 2020 04:00:00 Agreement State Agreement State Report - Patient Underdose ENS 545422020-02-20T05:00:00020 February 2020 05:00:00 Agreement State Agreement State Report - Gauge Failure ENS 544972020-01-29T05:00:00029 January 2020 05:00:00 Agreement State Agreement State Report - Stolen Nuclear Density Gauge ENS 544482019-12-13T05:00:00013 December 2019 05:00:00 Agreement State ENS 442862008-06-11T04:00:00011 June 2008 04:00:00 Agreement State Agreement State Report - Recovered Nuclear Material 2020-09-28T04:00:00 [Table view] | ||