Event Notification Report for February 02, 2012
U.S. Nuclear Regulatory Commission
Operations Center
EVENT REPORTS FOR
02/01/2012 - 02/02/2012
Agreement State
Event Number: 47633
Rep Org: UTAH DIVISION OF RADIATION CONTROL
Licensee: INTERMOUNTAIN MEDICAL CENTER
Region: 4
City: MURRAY State: UT
County:
License #: UT1800494
Agreement: Y
Docket:
NRC Notified By: PHILLIP GRIFFIN
HQ OPS Officer: STEVE SANDIN
Licensee: INTERMOUNTAIN MEDICAL CENTER
Region: 4
City: MURRAY State: UT
County:
License #: UT1800494
Agreement: Y
Docket:
NRC Notified By: PHILLIP GRIFFIN
HQ OPS Officer: STEVE SANDIN
Notification Date: 02/03/2012
Notification Time: 11:10 [ET]
Event Date: 02/02/2012
Event Time: 00:00 [MST]
Last Update Date: 02/03/2012
Notification Time: 11:10 [ET]
Event Date: 02/02/2012
Event Time: 00:00 [MST]
Last Update Date: 02/03/2012
Emergency Class: NON EMERGENCY
10 CFR Section:
10 CFR Section:
Person (Organization):
JEFF CLARK (R4DO)
ANGELA MCINTOSH (FSME)
JEFF CLARK (R4DO)
ANGELA MCINTOSH (FSME)
AGREEMENT STATE REPORT - DOSE DELIVERED TO WRONG PATIENT
The following report was received from the State of Utah via email:
"Two patients were scheduled to receive TheraSphere infusions containing microspheres of Yttrium-90 on the same day [02/02/12]. Patient #1 was to receive 5.32 GBq for a treatment dose of 120 Gy. Patient #2 was to receive 1.77 GBq for a treatment dose of 120 Gy. Patient #1 received the dosage for Patient #2 (i.e., 1.77 GBq). The error was detected prior to Patient #2 receiving a dosage. The licensee determined that Patient #1 received a dose that was 33% lower than the prescribed dose in the written directive. The licensee determined this to be a medical event. However, the licensee did not provide enough information to determine if this event is or is not an Abnormal Occurrence. An on-site investigation is planned by the Utah Division of Radiation Control to occur within the next several days."
Utah Event Report ID Number: UT120001.
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.
The following report was received from the State of Utah via email:
"Two patients were scheduled to receive TheraSphere infusions containing microspheres of Yttrium-90 on the same day [02/02/12]. Patient #1 was to receive 5.32 GBq for a treatment dose of 120 Gy. Patient #2 was to receive 1.77 GBq for a treatment dose of 120 Gy. Patient #1 received the dosage for Patient #2 (i.e., 1.77 GBq). The error was detected prior to Patient #2 receiving a dosage. The licensee determined that Patient #1 received a dose that was 33% lower than the prescribed dose in the written directive. The licensee determined this to be a medical event. However, the licensee did not provide enough information to determine if this event is or is not an Abnormal Occurrence. An on-site investigation is planned by the Utah Division of Radiation Control to occur within the next several days."
Utah Event Report ID Number: UT120001.
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.
Agreement State
Event Number: 47648
Rep Org: MINNESOTA DEPARTMENT OF HEALTH
Licensee: ABBOTT NORTHWESTERN HOSPITAL
Region: 3
City: MINNEAPOLIS State: MN
County:
License #: 1007-211-27
Agreement: Y
Docket:
NRC Notified By: TERESA PURRINGTON
HQ OPS Officer: CHARLES TEAL
Licensee: ABBOTT NORTHWESTERN HOSPITAL
Region: 3
City: MINNEAPOLIS State: MN
County:
License #: 1007-211-27
Agreement: Y
Docket:
NRC Notified By: TERESA PURRINGTON
HQ OPS Officer: CHARLES TEAL
Notification Date: 02/08/2012
Notification Time: 16:00 [ET]
Event Date: 02/02/2012
Event Time: 00:00 [CST]
Last Update Date: 06/08/2012
Notification Time: 16:00 [ET]
Event Date: 02/02/2012
Event Time: 00:00 [CST]
Last Update Date: 06/08/2012
Emergency Class: NON EMERGENCY
10 CFR Section:
10 CFR Section:
Person (Organization):
JOHN GIESSNER (R3DO)
PAUL MICHALAK (FSME)
JOHN GIESSNER (R3DO)
PAUL MICHALAK (FSME)
AGREEMENT STATE REPORT - Y-90 DOSAGE TO UNINTENDED AREAS
The following was received from the State of Minnesota via email:
"On February 3, 2012, Minnesota Department of Health Radioactive Materials unit received notice that a licensee had a medical event during a Y-90 SIRS spheres procedure. After infusion of radioactive Y-90, in the form of SIRS spheres for treatment of the liver, it was discovered, by follow-up radionuclide scanning, that some of the material was not in the liver as intended. Material appeared in vessels involving the spleen and digestive track instead. The amount has not been determined at this time, but it is possible that this may cause unintended, permanent, functional damage. The interventional radiologist involved with the treatment has ensured us that the patient will be notified along with the referring physician today. It is likely that some form of medical intervention will be taken.
"On February 6, 2012, the Radioactive Material supervisor and inspector met with the licensee to discuss the medical event. The Y-90 SIRS spheres procedure went accordingly to plan; it was discovered on the follow-up SPECT imaging that an estimated 10%-15% of the material was in the spleen, gastric fundus, and duodenum. The patient and ordering physician had been notified. The intended area for the material was the liver with an activity of 50 GBq. The three unattended areas that were discovered with material were estimated to receive a dose of 0. The Medical Physicist gave us the best preliminary dose estimates based on CT images obtained the day after the procedure at which the stomach and duodenum were different in shape. Early dose estimates for each region (spleen, gastric fundus, and duodenum) estimates approximately 30 Gy for each area.
"The Minnesota Department of Health Radioactive Materials unit will continue communication and obtain the final estimation for dose estimates."
* * * UPDATE FROM TERESA PURRINGTON TO VINCE KLCO AT 1055 EST ON 2/14/2012 * * *
The following information was received by email:
"Abbott Northwestern has submitted final best estimates pertaining to the medical event of Y-90 SIRS Spheres that occurred on Thursday, February 2, 2012. The final administered activity after accounting for loss in the delivery system was 1.53 GBq, original activity was 1.55 GBq. Estimates of radioactivity, organ volumes and radiation dose were derived by evaluation of SPECT CT images. The final best estimates are determined as follows:
"Organ / tissue Fraction of activity Volume (cc) Average dose (Gy)
Liver 0.839 1209 53
Fundus of stomach 0.058 101 44
Spleen 0.093 200 35
Portion of duodenum 0.010 41 35
"These estimates have a relatively high uncertainty (at least 20%) and local concentrations and doses may be significantly higher. Maximum concentrations per pixel in the SPECT images were as much as 50% higher than the average concentration."
Notified the R3DO (Passehl) and FSME EO (McIntosh).
* * * UPDATE FROM TERESA PURRINGTON TO DONALD NORWOOD at 1141 EDT on 6/8/2012 * * *
Event title edited to better characterize the event.
Notified R3DO (Passehl) and FSME_Events Resource both via E-mail.
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.
The following was received from the State of Minnesota via email:
"On February 3, 2012, Minnesota Department of Health Radioactive Materials unit received notice that a licensee had a medical event during a Y-90 SIRS spheres procedure. After infusion of radioactive Y-90, in the form of SIRS spheres for treatment of the liver, it was discovered, by follow-up radionuclide scanning, that some of the material was not in the liver as intended. Material appeared in vessels involving the spleen and digestive track instead. The amount has not been determined at this time, but it is possible that this may cause unintended, permanent, functional damage. The interventional radiologist involved with the treatment has ensured us that the patient will be notified along with the referring physician today. It is likely that some form of medical intervention will be taken.
"On February 6, 2012, the Radioactive Material supervisor and inspector met with the licensee to discuss the medical event. The Y-90 SIRS spheres procedure went accordingly to plan; it was discovered on the follow-up SPECT imaging that an estimated 10%-15% of the material was in the spleen, gastric fundus, and duodenum. The patient and ordering physician had been notified. The intended area for the material was the liver with an activity of 50 GBq. The three unattended areas that were discovered with material were estimated to receive a dose of 0. The Medical Physicist gave us the best preliminary dose estimates based on CT images obtained the day after the procedure at which the stomach and duodenum were different in shape. Early dose estimates for each region (spleen, gastric fundus, and duodenum) estimates approximately 30 Gy for each area.
"The Minnesota Department of Health Radioactive Materials unit will continue communication and obtain the final estimation for dose estimates."
* * * UPDATE FROM TERESA PURRINGTON TO VINCE KLCO AT 1055 EST ON 2/14/2012 * * *
The following information was received by email:
"Abbott Northwestern has submitted final best estimates pertaining to the medical event of Y-90 SIRS Spheres that occurred on Thursday, February 2, 2012. The final administered activity after accounting for loss in the delivery system was 1.53 GBq, original activity was 1.55 GBq. Estimates of radioactivity, organ volumes and radiation dose were derived by evaluation of SPECT CT images. The final best estimates are determined as follows:
"Organ / tissue Fraction of activity Volume (cc) Average dose (Gy)
Liver 0.839 1209 53
Fundus of stomach 0.058 101 44
Spleen 0.093 200 35
Portion of duodenum 0.010 41 35
"These estimates have a relatively high uncertainty (at least 20%) and local concentrations and doses may be significantly higher. Maximum concentrations per pixel in the SPECT images were as much as 50% higher than the average concentration."
Notified the R3DO (Passehl) and FSME EO (McIntosh).
* * * UPDATE FROM TERESA PURRINGTON TO DONALD NORWOOD at 1141 EDT on 6/8/2012 * * *
Event title edited to better characterize the event.
Notified R3DO (Passehl) and FSME_Events Resource both via E-mail.
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.