Event Notification Report for November 18, 2021

EN Revision Imported Date: 12/23/2021

EN Revision Text: AGREEMENT STATE REPORT - UNDERDOSE OF PATIENT

The following was a summary of an e-mail received by the state of California's Radiation Health Branch (RHB):

"The Radiation Safety Officer (RSO) at the licensee facility contacted the RHB and Los Angeles County Radiation Management (L.A. County) on November 22, 2021, to report a medical event. The event occurred on November 19, 2021. According to the RSO, a patient, who was part of a clinical trial, was under-dosed during a therapeutic treatment procedure for prostate cancer that involved the injection of actinium 225 (Ac-225) in the peripheral vein. The prescribed dose to the patient was 150 microcuries; however, the dose delivered was only 114 microcuries due to an accidental discharge of the radioisotope on the chux pad before it was administered to the patient. There was no spread of contamination. A site visit will be conducted to gain a better understanding of the details of the event."

California Event Number: 112221

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.

EN Revision Imported Date: 2/10/2022

EN Revision Text: AGREEMENT STATE REPORT - STUCK SHUTTER

The following was received via email from the Mississippi State Department of Health (the agency) via email:

"On 22 November 2021, the licensee notified the Agency by email regarding an incident that took place on 19 November 2021. The [Berthold Technologies] reciprocity crew, working under reciprocal recognition, was conducting turn around, replacing three gauge systems at the Licensee plant's Operating Processes. Two of the three sources retracted while one source was discovered to be stuck in the dip tube (Source Information: Co-60, 7.43 mCi, Manufacturer/Model: EG&G Berthold Model P-2608-100, Serial #: 1540-08-05, Device Information: Manufacturer EG&G Berthold, Device Model#: LB 7671, Serial Number: TBD). Reciprocity personnel attempted to dislodge the source to get it to retract but all attempts failed. The technician attached a blind plate (surveys below background) to prevent access and he documented surveys which the reciprocity personnel stated will be provided at a later time. According to the reciprocity licensee personnel, surveys were approximately 0.2 to 0.3 mR/hr at the detector side. Licensee personnel stated that the source is secured and remains shielded. Reciprocity licensee stated that they will continue to consider options to dislodge the source. The investigation into this event is ongoing and information will be provided as it is received in accordance with SA-300."

Mississippi Item Number: MS-210003

* * * RETRACTION ON January 10, 2022 AT 1726 EST FROM ROBERT SIMS TO TOM KENDZIA * * *

The following information was received from the Mississippi State Department of Health (the agency) via e-mail:

"Investigation findings indicate this event is not reportable. The highest survey reading is 0.2 mR per hour. This does not exceed public dose limit or an exposure that would cause a 25 milllirem TEDE. It is not lost or stolen. The source activity is 0.64 mCi. The source is at the top of the dip tube in the normal operating position in a safe position. The tank is approximately 30 foot tall and 20 foot wide in which the tank and the fluid is shielding the low activity source. The source will not expose the workers. The tank and gauge are on the 3rd floor of the refinery and only RSO's and workers supervised by RSO are allowed in this area.

"The engineer tried to remove it from this position for a scheduled source change out, and it could not be removed. At present, without shutting the production line down which makes plastic, this could cause a revenue loss of millions of dollars to the company. In the opinion of the Mississippi Health Physicist, this is not reportable. It does not meet SA 300 reporting requirements. The RSO has agreed to perform surveys at shift change and report any changes. This event is closed. If any changes occur and are reported. The agency will meet reporting requirements."

Notified R4DO (Groom) and NMSS Events (by email).

EN Revision Imported Date: 12/22/2021

EN Revision Text: AGREEMENT STATE REPORT - FOUND SOURCE

The following was received from the Ohio Department of Health Bureau of Radiation Protection (ODH) via email:

"Cohen Brothers, scrap metal facility in Middletown, informed ODH on November 19, 2021, that they discovered two devices containing radioactive material at their facility. An ODH inspector responded and identified the devices as Industrial Dynamics Filtec 3-G devices, each containing a 100 mCi Am-241 sealed source.

"Dose rates on the devices were 30 microR/hr. No contamination was detected. The gauges are secured at Cohen Brothers pending proper disposal.

"ODH is working with Industrial Dynamics to determine the owner of the devices."

The Filtec 3-G gauge serial numbers are 121015 and 121016.

Ohio Item Number: OH2100010

THIS MATERIAL EVENT CONTAINS A 'Less than Cat 3' LEVEL OF RADIOACTIVE MATERIAL

Sources that are "Less than IAEA Category 3 sources," are either sources that are very unlikely to cause permanent injury to individuals or contain a very small amount of radioactive material that would not cause any permanent injury. Some of these sources, such as moisture density gauges or thickness gauges that are Category 4, the amount of unshielded radioactive material, if not safely managed or securely protected, could possibly - although it is unlikely - temporarily injure someone who handled it or were otherwise in contact with it, or who were close to it for a period of many weeks. For additional information go to http://www-pub.iaea.org/MTCD/publications/PDF/Pub1227_web.pdf

EN Revision Imported Date: 12/22/2021

EN Revision Text: AGREEMENT STATE REPORT - DOSE MISADMINISTRATION

The following information was received from the state of Wisconsin via email:

"On November 22, 2021, the Department became aware of a medical event involving Y-90 TheraSphere which occurred on November 19, 2021. A patient had been prescribed two administrations to different segments of the liver of 126 Gy and 138 Gy. However, the licensee has estimated that the administered doses were 256 Gy (103 percent [over]) and 294 Gy (113 percent [over]). The administered doses had been ordered with an incorrect calibration date. A full dose projection is ongoing by the vendor. The State will perform a reactive inspection."

Wisconsin event no.: WI210010

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.

EN Revision Imported Date: 12/22/2021

EN Revision Text: AGREEMENT STATE REPORT - Y-90 UNDERDOSE

The following was received from the California Department of Public Health (CDPH) by email:

"On Saturday, November 20, 2021, at 0928 [PST], a CDPH-Radiologic Health Branch inspector was notified by e-mail that a medical event had occurred on Friday, November 19, 2021, at UCLA during a Y-90 liver cancer treatment. There were four liver segments being treated with four vials of Y-90 TheraSpheres. The prescribed dose for 'Segment 2' was 120 Gy, but the dose delivered was 74.9 Gy (or 62.42 percent of the prescribed dose). Segments 3, 6 and 8 were prescribed 120 Gy each and the doses delivered were 108.0 Gy, 110.9 Gy and 107.0 Gy (90 percent, 92.42 percent and 89.17 percent of the prescribed doses, respectively). Using the post treatment radiation surveys of the Nalgene waste container, a UCLA medical physicist determined that a medical event had occurred. The delivered dose to the organ differed by more than 20 percent from the prescribed dose.

"The authorized physician tried unsuccessfully to use a 2.0 Fr Truselect microcatheter for an hour to access the artery to segment 2, but it was extraordinarily small in caliber. He eventually chose to use a 1.7 Fr Echelon microcatheter for the treatment. Other treatment options were considered, but this particular tumor was in a location that was not amenable to ablation or chemoembolization. The patient will have a follow-up MRI scan in 3 months. A 15-day written report will be generated by the UCLA."

CA 5010 Number: 112021

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.

EN Revision Imported Date: 12/23/2021

EN Revision Text: AGREEMENT STATE REPORT - GAMMA KNIFE SHUTTER DOORS FAIL TO CLOSE

The following report was received via email from the New Jersey Department of Environmental Protection:

"While conducting the routine spot check prior to patient treatment with an Elekta Leksell Gamma Knife ICON unit, serial number 6114, the unit's shutter doors failed to close during the "Emergency Off" button test. The licensee's authorized medical physicist (AMP) followed emergency procedures and entered the room to manually close the doors. The doors closed, but the AMP decided to try again with the same result. The AMP carried a handheld survey meter with them each trip. Their calculated total exposure for their trips based on the exposure rate was 0.575 mR. There was no patient involvement. The unit is secured and Elekta is in the process repairing the unit. The licensee will follow-up with a full report."

EN Revision Imported Date: 12/17/2021

EN Revision Text: HIGH PRESSURE COOLANT INJECTION INOPERABLE DUE TO ISOLATION VALVE FAILURE TO AUTOMATICALLY OPEN

"On November 18, 2021, during the performance of High Pressure Coolant Injection (HPCI) surveillance testing, 23MOV-19 (HPCI PUMP DISCH TO REACTOR INBD ISOL VALVE) did not go open as expected while performing the sensed low water level portion of the test. The ability to manually open 23MOV-19 from the control room was unaffected as such, the HPCI system remained available for use. Failure of 23MOV-19 to open automatically prevents the HPCI system from performing its safety function as such this condition renders HPCI inoperable but available and is being reported as a condition that could have prevented the fulfillment of the safety function of a system needed to mitigate the consequences of an accident per 10CFR50.72(b)(3)(v)(D)."

HPCI inoperable placed the licensee in a 14-day limiting condition for operation for Tech Spec 3.5.1.c.

The NRC Resident Inspector was notified.