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The following information was provided by … The following information was provided by the North Dakota (ND) Department of Environmental Quality (DEQ) via telephone and email:</br>The ND DEQ received a call from Innovis Health, LLC, Fargo, North Dakota, (ND License No. 33-02604-01) at 0945 CDT on October 26, 2023, informing the ND DEQ of a possible medical event (10 CFR 35.3045(a)(1)) which occurred on October 25, 2023. The event involved a patient scheduled to receive a prescribed therapy dose of 120 Gy of yttrium-90 Theraspheres microspheres. During the line check while attempting to administer the microspheres, the licensee experienced some difficulties, stopped the procedure, and noticed a higher-than-normal radiation reading of the delivery system and associated materials. After measuring these materials, it appeared the patient received 41.7 Gy to the target site (liver). Initial imaging of the patient directly following the procedure did not show activity around the target area and surface radiation readings of the patient in this area was 0.06 mR/hr. At this time, the licensee was questioning if any of the dose was administered. The licensee contacted the manufacturer the same day regarding the event. </br>The licensee also noted increased radiation activity in other materials used in the procedure. The radiation survey reading of these materials was 140 mR/hr. The license was researching a way to calculate the amount of activity that may have been in these additional materials. </br>Further viewing of the images of the upper abdomen of the patient by the Interventional Radiologist (IR) demonstrated a very faint outline of the right lobe of the liver (the intended treatment area). This indicated a very small amount of the dose was delivered. The IR discussed everything with the patient before the patient had left the recovery area. There were no immediate adverse health effects, and the IR would monitor the patient for the next two weeks (about five half-lives).</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.
05:00:00, 25 October 2023 +
56,819 +
10:02:00, 27 October 2023 +
05:00:00, 25 October 2023 +
The following information was provided by … The following information was provided by the North Dakota (ND) Department of Environmental Quality (DEQ) via telephone and email:</br>The ND DEQ received a call from Innovis Health, LLC, Fargo, North Dakota, (ND License No. 33-02604-01) at 0945 CDT on October 26, 2023, informing the ND DEQ of a possible medical event (10 CFR 35.3045(a)(1)) which occurred on October 25, 2023. The event involved a patient scheduled to receive a prescribed therapy dose of 120 Gy of yttrium-90 Theraspheres microspheres. During the line check while attempting to administer the microspheres, the licensee experienced some difficulties, stopped the procedure, and noticed a higher-than-normal radiation reading of the delivery system and associated materials. After measuring these materials, it appeared the patient received 41.7 Gy to the target site (liver). Initial imaging of the patient directly following the procedure did not show activity around the target area and surface radiation readings of the patient in this area was 0.06 mR/hr. At this time, the licensee was questioning if any of the dose was administered. The licensee contacted the manufacturer the same day regarding the event. </br>The licensee also noted increased radiation activity in other materials used in the procedure. The radiation survey reading of these materials was 140 mR/hr. The license was researching a way to calculate the amount of activity that may have been in these additional materials. </br>Further viewing of the images of the upper abdomen of the patient by the Interventional Radiologist (IR) demonstrated a very faint outline of the right lobe of the liver (the intended treatment area). This indicated a very small amount of the dose was delivered. The IR discussed everything with the patient before the patient had left the recovery area. There were no immediate adverse health effects, and the IR would monitor the patient for the next two weeks (about five half-lives).</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, 27 October 2023 +
ND 33-02604-01 +
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12:30:04, 6 November 2023 +
10:02:00, 27 October 2023 +
2.21 d (53.03 hours, 0.316 weeks, 0.0726 months) +
05:00:00, 25 October 2023 +
TheraSphere + and Underdose +
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