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Event Notification Report for June 8, 2007

U.S. Nuclear Regulatory Commission
Operations Center

Event Reports For
06/07/2007 - 06/08/2007

** EVENT NUMBERS **


43398 43409 43412

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General Information or Other Event Number: 43398
Rep Org: WISCONSIN RADIATION PROTECTION
Licensee: AURORA ST. LUKE'S MEDICAL CENTER
Region: 3
City: MILWAUKEE State: WI
County:
License #: 079-1281-01
Agreement: Y
Docket:
NRC Notified By: SEAN MATYAS
HQ OPS Officer: STEVE SANDIN
Notification Date: 06/01/2007
Notification Time: 10:15 [ET]
Event Date: 05/31/2007
Event Time: [CDT]
Last Update Date: 06/07/2007
Emergency Class: NON EMERGENCY
10 CFR Section:
AGREEMENT STATE
Person (Organization):
KENNETH O'BRIEN (R3)
CYNTHIA FLANNERY (FSME)

Event Text

AGREEMENT STATE REPORT OF A MEDICAL EVENT INVOLVING AN UNDERDOSE

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

"Event Report ID No.: WI070011

"License No.: 079-1281-01
"Licensee: Aurora St. Luke's Medical Center

"Event Location: Aurora St. Luke's Medical Center, Milwaukee, WI

"Event Type: Medical Event
"Notifications: RSO called DHFS 5/31/2007

"Event description: On the morning of 5/31/2007 a Y-90 TheraSphere procedure was attempted. 1.05 GBq (28.3 mCi) was prescribed by the authorized user's written directive to deliver 123 Gy to the patient tumor. The activity in the dose vial was in agreement with this written directive. The TheraSphere Delivery Device (TDD) was appropriately set up by the radiopharmacist and the RSO, following the check list provided by the TheraSphere manufacturer, MDS Nordion. The interventional radiologist prepared the patient under fluoroscopy and positioned the catheter to fit his desired treatment site. This was completed at 9:30 a.m. At 9:40 the TDD was attached to the catheter. The TheraSphere injection was then started by the authorized user. The RSO was monitoring the radiation exposure in the room and did not see the normally-expected rise in exposure rate as the TheraSpheres enter the catheter and then the patient. After a few moments (after the injection of about half the balloon-inflator/syringe) the injection was stopped to evaluate what had happened. The authorized user and RSO then noticed that the blue stopcock was in the wrong position, directing the TheraSpheres into the waste vial and not into the patient.

"A radiation survey revealed that most of the radioactivity was now in the waste vial, very little (if any) in the patient, and some possibly remaining in the dose vial. It was decided to complete the normal four flushes of the dose vial into the patient, and to estimate the administered dose based on the activity in the waste vial.

"After the procedure the activity in the waste vial was measured in the dose calibrator in nuclear medicine. 25.9 mCi Y-90 was measured at 10:40 a.m. This constitutes approximately 94% of the activity that was originally in the dose vial (accounting for decay).

"The RSO estimates the dose delivered to the target volume in the patient liver is 6% of the intended dose, or 7 Gy.

"At 11:00 a.m. the RSO measured the exposure rate at the surface of the patient to be 0.00 Mr/hr with a GM survey meter and 0.0 Mr/hr with an ionization survey meter. Therefore, very little of the activity was injected into the patient. The waste vial is now being held for decay-in-storage. All personnel in the procedure, the TDD, and the room were surveyed and found to be free of contamination.

"The patient will be scheduled for re-treatment in the next few weeks.

"The licensee is evaluating the checklist provided by the manufacturer. DHFS will review the licensee's 15-day report and evaluate the licensee's proposed corrective actions.

"Media attention: None"

* * * UPDATE AT 1128 EDT ON 6/1/07 FROM FSME (FLANNERY) TO J. ROTTON * * *

This event (EN43398) has been reviewed and determined to be a reportable medical event.

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.

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Power Reactor Event Number: 43409
Facility: VERMONT YANKEE
Region: 1 State: VT
Unit: [1] [ ] [ ]
RX Type: [1] GE-4
NRC Notified By: DENNIS MAY
HQ OPS Officer: MARK ABRAMOVITZ
Notification Date: 06/06/2007
Notification Time: 14:32 [ET]
Event Date: 06/06/2007
Event Time: 13:17 [EDT]
Last Update Date: 06/07/2007
Emergency Class: NON EMERGENCY
10 CFR Section:
50.72(b)(3)(xiii) - LOSS COMM/ASMT/RESPONSE
Person (Organization):
RICHARD BARKLEY (R1)

Unit SCRAM Code RX CRIT Initial PWR Initial RX Mode Current PWR Current RX Mode
1 N Y 4 Startup 4 Startup

Event Text

PUBLIC NOTIFICATION SYSTEM INOPERABLE

"Notified at 1220 by Emergency Plan personnel that a tone test initiated by the National Weather Service from Albany, NY, failed to activate tone alert radios via the Ames Hill NOAA transmitter. Notified at 1317 that the WTSA Studio to transmitter link also failed to activate the tone alert radios. The tone alert radio system was working when a severe thunderstorm was issued at 1205 on 6-5-07."

The licensee has sent a technician to repair the transmitter.

The licensee notified the NRC Resident Inspector and will notify the states of Vermont, Massachusetts, and New Hampshire.

* * * UPDATE PROVIDED BY ANDREW WISNIEWSKI TO JEFF ROTTON AT 0931 ON 06/07/07 * * *

Repairs were completed to the tone alert radio system last night and testing was completed this morning. At 0821 the tone alert radio system was declared to be operable.

The licensee notified the NRC Resident Inspector and the states of Vermont, Massachusetts, and New Hampshire. Notified R1DO (Barkley)

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General Information or Other Event Number: 43412
Rep Org: CARBOLINE COMPANY
Licensee: CARBOLINE COMPANY
Region: 3
City: ST. LOUIS State: MO
County:
License #:
Agreement: N
Docket:
NRC Notified By: MARIKAY SPECKERT
HQ OPS Officer: STEVE SANDIN
Notification Date: 06/07/2007
Notification Time: 11:11 [ET]
Event Date: 06/07/2007
Event Time: [CDT]
Last Update Date: 06/07/2007
Emergency Class: NON EMERGENCY
10 CFR Section:
21.21 - UNSPECIFIED PARAGRAPH
Person (Organization):
MONTE PHILLIPS (R3)
RICHARD BARKLEY (R1)
PAUL FREDRICKSON (R2)
MICHAEL SHANNON (R4)
MJ ROSS-LEE (NRR)
VERNE HODGE (NRR)

Event Text

PART 21 REPORT INVOLVING CARBOLINE COATINGS

The following information was received via fax:

"Subject: 10CFR Part 21, Notification of Potential Safety Related Noncompliance Deviation
"Notification By: Carboline Company
"Phone: (314) 644-1000 x2456, Fax: (314) 644-4617

"Based on information supplied to Carboline Company (US) through Carboline Korea, Ltd. (Carboline's Korean affiliate), it is our understanding that Korea Power Engineering Company (KOPEC) has stated that the only Carboline material approved for use on KOPEC projects, is the Carboline Korea, Ltd. Material manufactured in Korea. Carboline Company's protective coatings manufactured in the US have not been tested or approved for KOPEC project work. We have not tested the Carboline US material to the KOPEC curve; the KOPEC curve is a 360F and the pressure is either 57 or 60 PSIG. This curve is more stringent than the standard curves used by US utilities.

"We have been made aware that, in some cases, material ordered from Carboline US and shipped as ordered, has in fact been utilized on units/equipment for KOPEC projects.

"Carboline (US) supplied Carboline US products as ordered. We are in most cases unaware of the end customer. The Carboline products supplied were manufactured in accordance with our 10CFR50 Appendix B QA program and we accept 10CFR Part 21 for all US orders of nuclear grade material.

"Note: Carboline Korea is not an approved sub-contractor/vendor under the Carboline US program and we have not supplied any Carboline Korea Ltd. Manufactured product to any US nuclear customer.

"From this point forward, Carboline material manufactured in the US will not be supplied for KOPEC project work.

"The following information is provided as required by 10 CFR 21.21(d) (4):

"(i) Name and address of individual informing the commission.

Dwayne Meyer, Director of Technical Resources and
Marikay Speckert, QA Manager
Carboline Company
350 Flanley Industrial Ct.
Brentwood, MO 63144

"(ii) Identification of the facility, the activity, or the basic component supplied for such facility or such activity within the United States which fails to comply or contains the defect.

"Protective Coatings ordered and supplied from Carboline Company (US); the only approved Carboline products for KOPEC work are those manufactured by Carboline Korea.

"(iii) Identification of the firm constructing the facility or supplying the basic component which fails to comply with or contains the defect.

"We do not know which Carboline (US) nuclear customers may have used US material when Carboline Korean manufactured material was required. We are notifying all NUPIC members and Carboline non-utility, nuclear customers that have purchased from Carboline Company (US) over the last 5 years.

"(iv) Nature of the defect or failure to comply and the safety hazard which is created by such a defect or failure to comply.

"Because we do not know who is using the material for KOPEC projects or the details of the material use; we do not have the capability to perform the evaluations to determine if a defect exists or the potential effect of such defect.

"We have not tested the Carboline US material to the KOPEC curve; the KOPEC curve is a 360F and the pressure is either 57 or 60 PSIG. This curve is more stringent than the standard curves used by US utilities.

"The Carboline Korea Ltd. Products are manufactured in our Korean plant for nuclear service. The Korean products have been tested and certified to meet KOPEC's specific performance and qualification standards. Carboline Company's (US) nuclear grade products are manufactured and qualified for nuclear service according to the standards set forth in the US. The formulations, raw material suppliers and the production processes are similar however they are not exactly the same and we do not know the significance of these differences.

"(v) The date on which the information of such defect or failure to comply was obtained.

"May 23, 2007, KOPEC informed us through our Carboline Korea affiliate, that we (Carboline US) needed to inform one of our customers that their undelivered component needed to be redone with Carboline Korean manufactured material.

"(vi) In the case of a basic component which contains a defect or fails to comply, the number and location of all such components in use at, supplied for, or being supplied for one or more facilities or activities subject to the regulations in this part.

"We do not know which Carboline (US) nuclear customers may have used US material when Carboline Korean manufactured material was required. We are notifying all NUPIC members and Carboline non-utility, nuclear customers that have purchased from Carboline Company (US) over the last 5 years.

"(vii) The corrective action which has been, is being, or will be taken; the name of the individual or organization responsible for the action; and the length of time that has been or will be taken to complete the action.

"1) We have informed our Sales Force and Customer Service personnel of the need to recognize/identify orders that are for use on international projects. We then contact the customer and clarify products required and facilitate getting material from Carboline Korea if needed. This was handled by Dwayne Meyer, our Director of Technical Resources, and has been in place for approximately two weeks.

"2) Our Korean made nuclear products will undergo a name change in the near future. This will help us clearly identify them on project specifications. This will assure that the products used on KOPEC projects use the same raw materials and the same processes at the same manufacturing plant location. This is being addressed by Doug Moore, our Director of International Business Development directly with our Carboline Korea management and this will be in place by July 1, 2007 at the latest. In the interim, we require that the coating requirement specification be supplied so that we can clearly identify the proper coating for the project.

"3) We are looking at having some Carboline Korea manufactured material stocked in Carboline (US) warehouse in our Lake Charles LA facility. Our QA department is working with our International Group. We are still looking into this; in the interim we are facilitating the orders for Carboline Korea material.

"(viii) Any advice related to the defect or failure to comply about the facility, activity, or basic component that has been, is being, or will be given to purchasers or licensees.

"We submitted the above plan (vii) to KOPEC and, through our affiliate; we understand that it is acceptable.

"In summary, Carboline has taken appropriate corrective action, notified the NRC, and shall notify all customers promptly.

"If you have any questions or need additional information concerning this notification, do not hesitate to contact Dwayne Meyer, Director of Technical Resources at (314) 644-1000 extension 2550, or Marikay Speckert, QA Manager at (314) 644-1000 extension 2456."

Page Last Reviewed/Updated Thursday, March 29, 2012
Thursday, March 29, 2012