ENS 54110
ENS Event | |
|---|---|
04:00 Jun 11, 2019 | |
| Title | Agreement State Report - Patient Under Dosage Due to Air Being Trapped in the Delivery Line |
| Event Description | The following report was received from the Georgia Department of Natural Resources via email:
A TheraSphere Y-90 patient did not receive the full dose to the target organ that was prescribed. The administered dose differed from the prescribed dose by more than 20 [percent]. The prescribed activity to be delivered to the patient was 2.15 GBq (58 mCi). The calculated delivered activity to the patient was 1.01 GBq (27.3 mCi). The delivered activity was determined by comparing pre-and post-administration survey meter measurements of the administration equipment, as per standard TheraSphere procedure. Radiological Analysis: Prescribed dose to target volume (liver): 127 Gy Administered dose to target volume (liver): 59.8 Gy Discussion and Outcome: On May 28, 2019, it was brought to the radiation safety officer's attention that a Y-90 TheraSphere administration had not delivered the full prescribed activity to the patient as intended. Upon further discussion it was noted that the performing physician noticed after connection of the line between the micro-catheter and the delivery vial that multiple air bubbles had become trapped in the line. He then created a closed system manifold using a three-way stopcock and syringes to effectively bleed out air bubbles and flush back as much of the dose as possible to the patient. The closed system prevented any spillage or contamination, and residual dose was retained in the syringes and stopcocks. Despite these actions taken by the physician, a post-administration assay of the waste container showed that the full desired activity had not made it out of the delivery equipment and into the patient. The procedure was a segmentectomy, and [the] patient will be re-evaluated in one month's time to determine if an additional therapeutic administration will be needed. Root Cause: Human error: Air was likely trapped somewhere in the system during the initial setup of the equipment. Operator technique failed to completely purge the lines of this air. Air bubbles in the line were not visible or not noticed prior to the connection of the line. Efforts to eliminate the air and deliver the full dose to the patient were then not successful. Corrective Actions and Actions to Prevent Further Occurrences: The nature of this event and the likely cause has been discussed with all staff involved in these procedures. A refresher training session has been scheduled for staff involved in these procedures. This training will be provided by a representative from BTG/TheraSphere starting on June 10, 2019. An additional step will be added to the procedure to visually and verbally confirm that there is no detectable air in the line between the micro-catheter and the dose vial prior to connection.
The NMED report number from the original report was removed. The new NMED report number was not obtained. NRC Event number 54684 was also created for this event and was deleted from the database. Notified R1DO (Schroeder) and NMSS Event 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 | |
|---|---|
| Georgia Radioactive Material Pgm Atlanta, Georgia (NRC Region 1) | |
| License number: | GA 292-1 |
| Organization: | Georgia Radioactive Material Pgm |
| Reporting | |
| Agreement State | |
| Time - Person (Reporting Time:+14.12 h0.588 days <br />0.084 weeks <br />0.0193 months <br />) | |
| Opened: | Irvin Gibson 18:07 Jun 11, 2019 |
| NRC Officer: | Jeff Herrera |
| Last Updated: | Apr 30, 2020 |
| 54110 - NRC Website | |
Georgia Radioactive Material Program with Agreement State | ||||
WEEKMONTHYEARENS 560652022-08-23T16:00:00023 August 2022 16:00:00 Agreement State Lost Radioactive Portable Gauge ENS 548822020-09-02T04:00:0002 September 2020 04:00:00 Agreement State | Agreement State Report - Medical Event - Underdose ENS 548792020-08-27T04:00:00027 August 2020 04:00:00 Agreement State | Agreement State Report - Loss of Medical Seed After Removal from Patient ENS 548172020-07-21T04:00:00021 July 2020 04:00:00 Agreement State | ENS 546942020-05-04T04:00:0004 May 2020 04:00:00 Agreement State Agreement State Report - Patient Underdose ENS 546622020-03-31T04:00:00031 March 2020 04:00:00 Agreement State Agreement State Report - Loss of Iodine-125 Seed ENS 541102019-06-11T04:00:00011 June 2019 04:00:00 Agreement State Agreement State Report - Patient Under Dosage Due to Air Being Trapped in the Delivery Line ENS 545492019-05-02T05:00:0002 May 2019 05:00:00 Agreement State Agreement State Report - Broken Density Gauge Shutter ENS 539962019-04-03T04:00:0003 April 2019 04:00:00 Agreement State Agreement State Report - Underdose Administration of Y-90 Theraspheres ENS 545502019-01-18T05:00:00018 January 2019 05:00:00 Agreement State Agreement State Report - Improper Disposal of I-125 Seed ENS 545412018-12-18T05:00:00018 December 2018 05:00:00 Agreement State Agreement State Report - Leaking Promethium-147 Source ENS 545652018-06-29T05:00:00029 June 2018 05:00:00 Agreement State Agreement State Report - Lost Iodine-125 Seed ENS 545372018-04-03T05:00:0003 April 2018 05:00:00 Agreement State Agreement State Report - Stuck Open Shutter ENS 545632017-11-06T05:00:0006 November 2017 05:00:00 Agreement State Agreement State Report - Leaking Cesium-137 Source ENS 546442017-06-09T04:00:0009 June 2017 04:00:00 Agreement State Agreement State Report - Stuck Shutter ENS 545642016-08-09T05:00:0009 August 2016 05:00:00 Agreement State Agreement State Report - Lost I-125 Source 2022-08-23T16:00:00 [Table view] | |