Event Notification Report for March 08, 2018

PART 21 NOTIFICATION - DEFECT REGARDING CERTAIN PRESSURE TRANSMITTERS AND AMPLIFIER CIRCUIT CARD ASSEMBLIES

The following notification is an excerpt from the received report:

"Pursuant to 10 CFR Part 21, section 21.21(b), Rosemount Nuclear Instruments, Inc. (RNII) is writing to inform you that a total of eleven (11) Model 1154 and 1154 Series H output range code 4 pressure transmitters whose model code includes special option suffix N0026 or N0087 and five (5) 01154-0153-0002 Amplifier Circuit Card Assemblies may not calibrate at all the published values.

"Name and address of the individual providing the information:
Mr. Gerard Hanson
Vice President & General Manager
Rosemount Nuclear Instruments, Inc.
8200 Market Blvd
Chanhassen, MN 55317

"Nature of the failure and potential safety hazard: During evaluation of two returned 01154-0153-0002 Amplifier Circuit Card Assemblies (CCAs), it was observed that a single resistor (R316) on each affected Amplifier CCA had an incorrect resistance value.

"The N0026 and N0087 special options enable a standard upper range limit (URL) of a transmitter with output range code 4 to be increased from 150 inches water to 210 inches water, in combination with a minimum span of 75 inches water. This R316 resistor allows the transmitter to achieve performance specifications, calibration ranges, and spans as indicated by the special option drawing.

"In the sub-assembly process, the R316 resistor on a standard Amplifier CCA is replaced to create a new Amplifier CCA part number (01154-0153-0002). The R316 resistor enables the standard lower range limit (LRL) of a transmitter with output range code 4 to be decreased from -150 inches water to -210 inches water (negative pressure values imply pressure applied to the low-pressure side of the transmitter), in combination with a minimum span of 75 inches water. This R316 resistor allows the transmitter to achieve performance specifications, calibration ranges, and spans as indicated by the special option drawing.

"The new resistor's material traceability information is recorded on the traveler. In final assembly, each transmitter with special option suffix N0026 and N0087 is assembled using one of these 01154-0153-0002 Amplifier CCAs. It then receives a factory calibration check at 135 inches water to 210 inches water and customer specified calibrated range, to ensure conformance to the minimum span and maximum URL specifications, as defined by the special option drawing. Appropriate manufacturing paperwork is used to document and record each Amplifier CCA serial number, as well as each final assembly transmitter.

"To meet site specific application requirements, transmitters may be field recalibrated to different upper and lower range values and/or spans. Model 1154 and 1154 Series H transmitters with special option suffix N0026 or N0087 and Amplifier CCAs whose R316 resistors were not replaced during the sub-assembly process, will have incorrect resistance values and may not calibrate to all upper and lower range values and/or spans published for the applicable special option. However, if an affected transmitter has been successfully calibrated, having the incorrect resistance value will not adversely affect transmitter performance specifications during normal operation or accident conditions.

"The manufacturing records for the two returned Amplifier CCAs, part number 01154-0153-0002, were carefully reviewed. The sub-assembly traveler lacked the required material traceability information, indicating that the R318 resistors were not replaced. RNII reviewed all sub-assembly travelers for part number 01154-0153-0002. The issue has been isolated to one lot which included (16) Amplifier CCAs.

"On March 8, 2018, RNII concluded that a substantial safety hazard may exist.

"The corrective action which has been taken; the name of the individual or organization responsible for that action; and the length of time taken to complete that action:

"(a) RNII previously discontinued manufacturing 01154-0153-0002 Amplifier CCAs, there are no Amplifier CCAs currently in production or finished goods.

"(b) RNII examined all manufacturing paperwork for all 01154-0153-0002 Amplifier CCAs, and other than the single lot of (16) Amplifier CCAs described above, no additional discrepancies were found.

"Any advice related to the potential failure of the item: The end user is advised to determine the impact of this potential non-conformance on its plant operations and safety and take action as deemed necessary. Affected 01154-0153-0002 Amplifier CCA(s) and transmitter(s) can be returned to RNII for rework. Contact RNII to facilitate the return process.

"If there are any questions, or you require additional Information related to this issue, please contact: Mike Dougherty (206) 665-1112, Paul Schmeling (952) 949-5359, or Brian VanderWoude (952) 949-5207.

"Shipped as piece parts (P/N 01154-0153-0002) to Arkansas Nuclear One and Waterford.

"Shipped as part of transmitter (N0026 and N0087) to Palo Verde, St. Lucie, and Calvert Cliffs."

MEDICAL EVENT INVOLVING DELIVERED DOSE 50 PERCENT LESS THAN PRESCRIBED DOSE

A patient was prescribed 8 fractions of 500 cGy to the temple area. During the third fraction, the physician noticed the first two fractions were performed incorrectly. The first two fractions were performed with an incorrect setup, and the patient received less than 50 percent of the prescribed dose to the temple. The Radiation Safety Officer will provide a detailed written report after an investigation.

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.

PATIENT RECEIVED DOSE LESS THAN PRESCRIBED DOSE

The following was received from the licensee via email:

"On March 8, 2018 and March 12, 2018, the patient was treated with the incorrect setup. On March 15, 2018, the patient was treated with the correct setup. Following the third treatment, both physicists were in the HDR [High Dose Rate] vault. The patient's setup was still on the treatment table, the physicist who had delivered the first two treatments noticed the accuform in the setup. At this time the patient had already left the facility. His next treatment was scheduled for March 19, 2018. This was discussed with the physician and the decision was made to perform a CT without the accuform, prior to the next treatment. The plan was recreated, using the same dwell weights and positions as the original plan. At this point we discovered that the patient had been under-dosed by more than 50 percent. Physics notified the NRC and the prescribing physician.

"As a result of the misadministration discovered March 19, 2018, a root cause analysis was performed. The direct cause of the incident was the failure to properly recreate the initial patient setup. The exclusion of the accuform caused the patient's head to be in the wrong position, leaving a gap between the treatment device and the patient's skin.

"Contributing factors include the lack of a specific policy regarding custom immobilization in HDR procedures, this was only the second brachytherapy patient using custom immobilization, the pictures from the simulation did not completely show the accuform, and it is generally a therapist, not a physicist, who reproduces the daily setup using custom immobilization.

"Items identified during root cause analysis: 1. At the time of treatment, there was not a policy specifically written for skin brachytherapy 2. The accuform was not used in the patient setup 3. The pictures from the simulation did not completely show the custom setup. 4. At the time of the incident there was not a verification system in place, to track the items needed for each custom setup.

"Corrective actions: 1. A policy was created and provided to [NRC R4 (Simmons)] on April 4, 2018. 2. Our new policy ensures that a therapist will be present at the first treatment, and any time a physicist is treating the patient for the first time. 3. In the CT simulation, any custom immobilization used in brachytherapy will be photographed with and without the patient. This will ensure that each piece of the custom device can be clearly visualized. Our IT department will be installing a computer monitor, keyboard and mouse in the HDR treatment vault. This will allow the verification of the setup notes and photographs in the treatment room. 4. Physics is working with our IT department and Elekta to implement a bar code scanning system to track custom setup devices."

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.

60-DAY OPTIONAL TELEPHONIC NOTIFICATION FOR AN INVALID EDG START DURING OUTAGE TESTING

"On March 8, 2018, an invalid system actuation occurred while preparations were underway to perform Safety Features Actuation System (SFAS) integrated response time surveillance testing during the recent Davis Besse Nuclear Power Station refueling outage. Several minutes after connecting a data recorder to monitor the Emergency Diesel Generator (EDG) 1 start signal, at 1323 hours [EST], the EDG started with no valid actuation signals or test inputs present. The EDG successfully came up to speed and voltage as expected. The associated essential 4160 volt electrical bus remained energized from the normal power supply, therefore, the EDG output breaker did not close to supply power to the bus. Troubleshooting determined the inadvertent actuation was due to a short in the test lead wires at the recorder connection caused by a faulty test lead. The test lead was replaced and the SFAS surveillance testing completed satisfactorily.

"This event is being reported as an invalid system actuation per 10 CFR 50.73(a)(2)(iv)(A); this 60-day optional telephone notification is being made per 10 CFR 50.73(a)(i) in lieu of submitting a written Licensee Event Report.

"The NRC Resident Inspector was notified of the inadvertent EDG start at the time of the event and has been notified of this invalid specified system actuation notification."