Event Notification Report for March 08, 2011

ONSITE FATALITY

"At 0357 [EST on 3/8/11] the licensee received a call for medical assistance. The caller reported an individual [contract employee] had passed out but was still breathing. Our [McGuire] onsite medical response team reported the person was not breathing and in cardiac arrest. The person was transported offsite via ambulance [Gileade Volunteer Fire and Rescue] to the local hospital. At 0602 EST, the licensee received word that the individual had passed away at the hospital."

The licensee will notify the NRC Resident Inspector

GNF PROCEDURE 40-32 LOSS OF A SINGLE MATERIAL CONTROL TRANSACTION

"At approximately 7:00 a.m. on Monday, March 7th, it was reported that a can of powder was present on a conveyor in the UO2 press feed area without the required material control transaction. At approximately 10:10 a.m. it was discovered that the can contained three vacuum bags of powder. The transaction is one criticality control for the conveyor to ensure only authorized dry materials are stored.

"The second controlled parameter (mass of uranium in each can) was maintained at all times. As a result, no unsafe condition existed. The total amount of UO2 powder in the improperly stored can was approximately 13.6 kg. The material control transactions have been properly performed and the can has been transferred to an approved storage location.

"As a result, SNM movements have been ceased pending investigation and implementation of additional corrective actions."

The licensee has notified the NRC Resident (Thomas), New Hanover County Emergency Management, and North Carolina of Environment and Natural Resources.

AGREEMENT STATE REPORT - POTENTIAL MEDICAL EVENTS INVOLVING CARDIOGEN-82 RADIOISOTOPE GENERATORS USED FOR CARDIAC STRESS TESTING

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

"Description: A patient who received a Rubidium stress test on March 8th 2011 was detected at a security checkpoint upon reentry to the United States. The patient was determined to have higher than expected levels of strontium. The patient was referred to Oak Ridge National Laboratory to undergo sensitive whole body counting. The whole body counting indicated an expected dose of 4.9 rem. Additional testing conducted by the Nevada Radiation Control Program was performed on 203 patients. The result of each scan was compared to the patient who received the whole body counting at Oak Ridge National Laboratory. The definition of a medical event is '[a] dose that differs from the prescribed dose or dose that would have resulted from the prescribed dosage by more than 0.05 Sv (5 rem)' and that 'differs from the prescribed dose by 20 percent or more.' [10 CFR º 35.3045]. Because the patient who received the whole body counting at Oak Ridge received 4.9 rem any patient who had more activity when compared to the Oak Ridge patient may qualify as a medical event. The analysis of the scans indicates 38 patients had an exposure that may constitute a medical event. The following table identifies the date, number of patients on a specific date, and the total number of patients that may have received Sr-82 and Sr-85 in sufficient quantities to constitute a medical event. The investigation is ongoing and includes the Nevada Radiation Control Program, Food and Drug Administration ('FDA'), BRACCO, and Nevada Heart and Vascular. As information becomes available the actual number of medical events may change and will be updated at that time.

"Date Of Injection # Of Patients

2/11/2011 6
3/7/2011 2
3/8/2011 5
3/9/2011 3
3/10/2011 5
3/11/2011 2
3/12/2011 3
3/13/2011 4
3/14/2011 1
3/15/2011 2
4/5/2011 1
4/7/2011 4

Total Patients 38

"Why The Event Occurred: The events are still under investigation. The events may be related to manufacturing defects, inadequate training procedures, or a combination of both. 'Based on further investigation, FDA has determined that the current CardioGen-82 manufacturing procedures are not sufficient to ensure reliable performance of the generator used to produce the Rb-82 chloride injection' (FDA, 7-26-2011).

"The Effect, if any, on the Individuals Who Received the Administration: The exposure is still under investigation. However, no deleterious effects are expected as a result to the exposure. Concerning this issue, 'Oak Ridge National Laboratory determined the estimated amount of unexpected radiation to be minimal and similar to what other patients may receive with cumulative exposure to certain other types of cardiac imaging procedures' (Giordano, K. & McDaniel, K., 2011).

"What Actions, if any, Have Been Taken, or are Planned to Prevent Recurrence: The FDA alerted healthcare professionals to stop use of CardioGen-82 for Cardiac PET scans and BRACCO decided to voluntarily recall CardioGen-82 and this will prevent recurrence. (FDA, 7-26-2011). In addition, all technologists have undergone retraining by BRACCO and shall adopt BRACCO's updated policy concerning breakthrough testing. An online worksheet has been constructed to simplify and monitor the breakthrough recording process.

"Additional actions may be implemented based on the investigation's findings.

"Certification that the licensee notified the individual (or the individual's responsible relative or guardian), and if not, why not.

"All patients who received studies on the dates referenced above have met with their referring physician concerning the elevated exposure to strontium. This is included in the patient's chart as part as their medical record. The Nevada Radiation Control Program has also contacted patients concerning the elevated strontium exposure.

"Event Cause: Equipment Failure

"Corrective Action: Reevaluation of CardioGen-82 design, training procedures and quality control.

"Device/Associated Equipment: CardioGen-82 manufactured by BRACCO Diagnostics."

NV Report No.: NV110023

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.

UNPLANNED MEDICAL TREATMENT OF POTENTIALLY CONTAMINATED INDIVIDUAL

"A contract employee entered the onsite medical facility with a laceration on his right arm. First aid was administered in preparation for transferring to an offsite medical facility. The employee had spreadable contamination on his clothing (60dpm/100cm2). The employee was decontaminated before leaving the site. The employee received 8 stitches at the offsite medical facility."