Event Notification Report for January 21, 2010

AGREEMENT STATE REPORT - BRACHYTHERAPY IMPLANTS OUTSIDE OF THE INTENDED TREATMENT AREA

The following information was received via fax:

"Notifications: The licensee called the PaDEP Southeast Regional Office on the morning of February 25, 2010 to provide a 24-hour verbal notice of a possible Medical Event. The SERO and Central Office discussed the known facts around noon time, and understood the U Penn RSO would be providing more information via email. DEP also provided a verbal notice to NRC Region 1 regarding this possible ME on 2-25-2010.

"On January 21, 2010 a patient was treated by brachytherapy for prostate cancer with sixty five (65) iodine-125 (I-125) seeds. The I-125 seeds were implanted using real time dosimetry under ultrasonic guidance. The written directive called for a therapeutic radiation dose of 145 gray (Gy) [14,500 rad] to the prostate volume, plus 5 millimeters of margin, using interoperative planning. On February 23, 2010, the patient returned for a 30 day post-implant CT. The scan showed that the implanted seeds were "in an appropriate pattern," but outside the intended target. On February 24th the licensee's Radiation Oncology group determined that an additional quality assurance review was warranted, but the RSO should notify PaDEP/BRP [Pennsylvania Department of Environmental Protection/Bureau of Radiation Protection] regarding the case. Based on the information known at this time, PaDEP/BRP believes this ME is reportable under 10CFR35.3045, and may be an Abnormal Occurrence (AO). The state will perform a reactive inspection next week, and coordinate with NRC Region I; because of their ongoing evaluation of pre-April 2008 brachytherapy implants at U Penn, and at the Philadelphia VA hospital.

"Cause of the event: A new ultrasound unit that was used to place the I-125 seeds may have been malfunctioning.

"Actions: There is a reactive inspection scheduled to investigate this apparent ME at U Penn on March 2, 2010. PaDEP/BRP will also ask U Penn to evaluate the need for FDA notification regarding the ultrasound unit."


Event Report ID Number: PA100002

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.

AGREEMENT STATE REPORT - BRACHYTHERAPY UNDERDOSE

The following was received via E-mail:

"On January 22, 2010 the BRP [Ohio Bureau of Radiation Protection] was notified of a medical event that occurred at the Jewish Hospital of Cincinnati on January 21, 2010. The patient received 67% of the prescribed dose to the prostate implant with I-125 seeds. The physician is attempting to contact the patient. The BRP will investigate the event."

The prescribed dose was 144 Gy and the actual dose delivered was 96.48 Gy

Ohio Incident: OH100001

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.

AUTOMATIC REACTOR TRIP DUE TO LOW STEAM GENERATOR WATER LEVEL

"On January 21, 2010, at 1820 hours, Salem Unit 2 had an Automatic Reactor Trip due to low steam generator (SG) water level in the 22 SG. Prior to the reactor trip, the 21 SG feedwater pump tripped due to low oil pressure. A turbine runback was in progress and SG levels failed to recover. [Also at the time of the reactor trip], the 22 SG feedwater pump tripped on overspeed.

"All rods fully inserted on the trip and all systems responded as designed with decay heat being removed via the Steam Dump system, with condenser vacuum maintained. All three AFW Pumps auto started due to low Steam Generator level. Following the trip, the 22 Reactor Coolant Pump (RCP) flange vibration level spiked to approximately 9 mils and returned to a normal value of 2.6 mils. 22 RCP remained in service following the trip. The 21RS12 low pressure turbine intercept valve failed to indicate closed following the turbine trip but was locally verified closed.

"Salem Unit 2 is currently in mode 3. The Reactor Coolant System temperature is 547 degrees F with pressure at 2235 psig (NOT and NOP). All ECCS and ESF Systems are available and no ECCS systems actuated during the event. No personnel injuries occurred as a result of the trip."

There is no primary to secondary leakage. The electrical shutdown configuration is normal. There was no impact on Unit-1.

The licensee notified the NRC Resident Inspector.

AGREEMENT STATE REPORT - POTENTIAL LOSS OF AN X-RAY FLUORESCENCE DEVICE SOURCE

Thermo-Niton Analyzers LLC was expecting the delivery of an X-Ray Fluorescence device. The carrier was contacted and no delivery was scheduled for that location. The carrier is reviewing records to ascertain where the package is and whether it was delivered to the licensee's previous address. The state did not know the model number of the device or if there was a radioactive source in this device.

Thermo-Niton has two Massachusetts licenses: 55-0238 and 53-0388

* * * UPDATE ON 1/22/2010 AT 1129 FROM TONY CARPENITO TO MARK ABRAMOVITZ * * *

The following report was received via e-mail:

"On 1/8/10, Thermo-Niton Analyzers LLC (Thermo) of Billerica, MA, shipped a Niton Portable XRF Analyzer (Model XL-801S, SN U1834, Source IPL Model XFB Series) to REM Aerospace of Fort Lauderdale, FL. On 1/12/10, REM Aerospace informed Thermo the device not yet been received. Subsequent communications determined that REM Aerospace had relocated and the device had been inadvertently shipped to REM Aerospace's previous address. Thermo contacted [the carrier] who returned to the original address on several occasions to recover the package. These attempts to recover the package were unsuccessful. On 1/21/10, Thermo contacted the MA and FL Radiation Control Programs and the Fort Lauderdale Police Department."

The XRF Analyzer contains a 10 milliCi Cadmium-109 source.

Notified FSME (Camper) and R1DO (Bellamy)