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The following report was received from the … The following report was received from the Georgia Department of Natural Resources via email:</br>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).</br>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.</br>Radiological Analysis:</br>Prescribed dose to target volume (liver): 127 Gy</br>Administered dose to target volume (liver): 59.8 Gy</br>Discussion and Outcome:</br>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.</br>Root Cause:</br>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.</br>Corrective Actions and Actions to Prevent Further Occurrences:</br>The nature of this event and the likely cause has been discussed with all staff involved in these procedures.</br>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.</br>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.</br>* * * UPDATE FROM IRENE BENNETT TO HOWIE CROUCH (VIA EMAIL) ON 4/30/20 AT 1323 * * *</br>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.</br>Notified R1DO (Schroeder) and NMSS Event Notification (email).</br>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.necessarily result in harm to the patient.
04:00:00, 11 June 2019 +
54,110 +
18:07:00, 11 June 2019 +
04:00:00, 11 June 2019 +
The following report was received from the … The following report was received from the Georgia Department of Natural Resources via email:</br>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).</br>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.</br>Radiological Analysis:</br>Prescribed dose to target volume (liver): 127 Gy</br>Administered dose to target volume (liver): 59.8 Gy</br>Discussion and Outcome:</br>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.</br>Root Cause:</br>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.</br>Corrective Actions and Actions to Prevent Further Occurrences:</br>The nature of this event and the likely cause has been discussed with all staff involved in these procedures.</br>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.</br>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.</br>* * * UPDATE FROM IRENE BENNETT TO HOWIE CROUCH (VIA EMAIL) ON 4/30/20 AT 1323 * * *</br>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.</br>Notified R1DO (Schroeder) and NMSS Event Notification (email).</br>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.necessarily result in harm to the patient.
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00:00:00, 30 April 2020 +
GA 292-1 +
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16:40:40, 15 January 2021 +
18:07:00, 11 June 2019 +
0.588 d (14.12 hours, 0.084 weeks, 0.0193 months) +
04:00:00, 11 June 2019 +
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