Event Notification Report for October 16, 2018

AGREEMENT STATE REPORT - ADMINISTERED DOSE LOWER THAN PRESCRIBED DOSE

The following information was obtained from the State of Ohio via email:

"On October 16, 2018, a suspected medical event occurred. A patient was prescribed a dose of 120 Gy for segment 4 of the left lobe of the liver involving Y-90 TheraSpheres. All the pre-procedural safety checks were made and appropriate imaging (cone beam CT) was performed to check the catheter position and lesion location. During the first set of infusions, there was high resistance felt on the syringe which continued for the next few infusions. It was decided to stop the treatment as there was risk of inadequate delivery of the microspheres due to possibility of stasis and concern for non-target embolization to other sites. The residual was calculated and it was noted that estimated dose delivered was 6.4 Gy to the target lesion. Post-procedure, the patient had a PET CT to check the Y-90 microspheres distribution and it did not demonstrate any non-targeted deposition.

"The administered dose was 6.4 Gy to segment 4 of the left lobe of the liver. The dose was therefore 5% of the prescribed dose, a 95% difference.

"The microspheres not delivered to the target were contained in the catheter. No contamination occurred as a result of this event.

"The referring physician has been notified as well as the patient.

"A follow-up inspection will be conducted during the week of Oct. 22, 2018."

Ohio NMED Report No.: OH180010

* * * RETRACTION ON 7/23/2019 AT 1526 EDT FROM MICHAEL RUBADUE TO ANDREW WAUGH * * *

The following retraction was obtained from the State of Ohio via email:

"A follow-up inspection was conducted on October 24, 2018 to determine the circumstances leading up to this event.

"It was determined the difference in administered dose was due to emergent patient conditions and resistance of the patient's complex hepatic arterial system; stasis. There was no evidence of catheter misplacement, non-target disposition or mechanical failure of the Y-90 microsphere delivery system. There was also no evidence of any non-compliance with NRC guidelines or Ohio Administrative Code regulations."

Notified R3DO (Norton) and NMSS Events 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.

INABILITY TO RETRACT A SOURCE TO ITS SHIELDED POSITION

The following information was received via email:

"On October 16th 2018, The ExxonMobil RSO at the Billings Montana Refinery (License # 25-03375-01) notified USNRC of one (1) device (insertion type nuclear gauge) that failed to function as designed (10 CFR 30.50.Section B.2).

"Device Information: Ohmart device, model MT-93-439-001 with 10 mCi. of Cs-137; S/N: 0692GK; Source capsule model: A-2102 (X38/2); Manufacture date: Nov 7th, 1994

"Upon locking out the nuclear gauge at approximately 11:00am, the nuclear gauge user identified that the cable connecting the source capsule housing (torpedo) to the source holder retrieval mechanism had become detached. The source capsule housing appears to be in its normal operating location at the bottom of the equipment guide tube in the boot of the vessel, however, due to the disconnected cable it cannot be retrieved. The following precautionary measures were taken to ensure minimal potential for exposure (1) no vessel entry permits will be issued for the vessel (2) the area around the boot was barricaded to restrict entry.

"There is no additional risk of radiation exposure to members of the general public or radiation workers due to the failure of the equipment function.

"The source capsule housing is scheduled to be retrieved, shielded, and shipped for transfer to QSA Global by VEGA Americas, Inc. on 10/18/18."

AGREEMENT STATE REPORT - EQUIPMENT FAILURE

The following was received from the State of Nebraska:

"Event type: Equipment Failure as reportable under 10 CFR 30.50, item b.2. and Inoperability of Access Control System under 10 CFR 36.83, item 5.

"Event description: Nebraska Department of Health and Human Services, Office of Radiological Health was conducting a performance-based inspection of the Becton Dickinson and Company licensee (10-08-01) during the late afternoon (between 2:30 and 3:30 pm) on October 16, 2018. During the inspection, an inspector was able to open an outer door leading from the production floor area to the control room, which is a part of the licensee's controlled access area. The control room also contains an access door which leads to a panoramic, wet source storage irradiator licensed for millions of curies of Co-60. The access door in the control room did not fail and was functioning as intended. The outer door leading to the control room was able to be opened by the inspector only after a routine entry was made. During the initial inspection by the licensee, it was determined that the locking mechanism was loose and did not latch as intended. The licensee was able to repair the locking mechanism within 2 hours and could not open the outer door after a routine entry was made.

"The State inquired with the Region IV Regional State Agreement Officer (RSAO) in the early afternoon (between 1:30 and 2:30pm) of October 17, 2018 to ask if this incident was a reportable event under 10 CFR 37. The RSAO indicated and agreed that this incident was not a report event under the reporting requirements of 10 CFR 37. Later that afternoon (between 3:30 and 4:00 pm), the RSAO stated that this incident may be a reportable event under 10 CFR 30.50, item b.2. and 10 CFR 36.83, item 5.

"The State and Region IV staff are scheduled to discuss this further on October 18, 2018, and this incident may need to be retracted.

"State Event Report ID No.: NE-18-0008"

* * * RETRACTION ON 10/18/2018 AT 1129 EDT FROM LARRY HARISIS TO ANDREW WAUGH * * *

The following retraction was received from the State of Nebraska via email:

"Please retract this event. This does not meet the reporting requirements of either 10 CFR 30.50 or 10 CFR 36.83 since this outer door is not a part of the access control system. This was reviewed and discussed by State staff and NRC Region IV staff this morning."

Notified R4DO (Pick) and NMSS Events Notification (email).