Event Notification Report for April 03, 2020
U.S. Nuclear Regulatory Commission
Operations Center
EVENT REPORTS FOR
04/02/2020 - 04/03/2020
EVENT NUMBERS
54641
Agreement State
Event Number: 54641
Rep Org: PA BUREAU OF RADIATION PROTECTION
Licensee: ALBERT EINSTEIN HEALTHCARE NETWORK
Region: 1
City: PHILADELPHIA State: PA
County:
License #: PA-0135
Agreement: Y
Docket:
NRC Notified By: JOHN CHIPPO
HQ OPS Officer: KERBY SCALES
Licensee: ALBERT EINSTEIN HEALTHCARE NETWORK
Region: 1
City: PHILADELPHIA State: PA
County:
License #: PA-0135
Agreement: Y
Docket:
NRC Notified By: JOHN CHIPPO
HQ OPS Officer: KERBY SCALES
Notification Date: 04/06/2020
Notification Time: 14:09 [ET]
Event Date: 04/03/2020
Event Time: 00:00 [EDT]
Last Update Date: 04/07/2020
Notification Time: 14:09 [ET]
Event Date: 04/03/2020
Event Time: 00:00 [EDT]
Last Update Date: 04/07/2020
Emergency Class: Non Emergency
10 CFR Section:
AGREEMENT STATE
10 CFR Section:
AGREEMENT STATE
Person (Organization):
JON LILLIENDAHL (R1DO)
NMSS_EVENTS_NOTIFICATION (EMAIL)
JON LILLIENDAHL (R1DO)
NMSS_EVENTS_NOTIFICATION (EMAIL)
AGREEMENT STATE REPORT - PATIENT UNDERDOSE
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
* * * UPDATE ON 04/07/2020 AT 1353 EDT FROM JOHN CHIPPO TO JEFFREY WHITED * * *
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.
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
* * * UPDATE ON 04/07/2020 AT 1353 EDT FROM JOHN CHIPPO TO JEFFREY WHITED * * *
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.