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| Entered date | Event description | |
|---|---|---|
| ENS 50091 | 6 May 2014 15:15:00 | I am reporting a Medical Event and Abnormal Occurrence. The event resulted from incorrect dosage administered to the patient for the second phase of the yttrium-90 SirSperes for treatment of the liver. The patient was administered 43 millicuries of Y-90 for the second phase instead of 12 to 12.5 mCi as intended. The event occurred at Cedars Sinai Medical Center (California Radioactive Materials License number 0404-19) in Los Angeles, CA, on April 30, 2014. Los Angeles County Public Health, Radiation Management was notified on May 1, 2014. During the original report date, the licensee did not have any information regarding the radiation dose to the patient and was working with their Medical Physicists. On May 6, 2014, Cedars Sinai Medical Center reported that the patient received 363 Gray instead of the intended dose within the range of 53-102 Gray. Per the licensee, both the patient and referring physicians have been notified. The patient has not reported any side effects that were unanticipated and the patient will continue to be medically monitored. 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. |
| ENS 50647 | 2 December 2014 17:15:00 | The following is a synopsis of information received via E-mail: The Cedars Sinai Medical Center (CSMC) Radiation Physics Manager (RPM) contacted Los Angeles County Radiation Management (LA County) via telephone to report a potential medical event that had occurred at CSMC. The RPM stated that the event resulted from a dosage administration to the patient of yttrium-90 SIR-Spheres less than that prescribed. LA County requested that a written report be submitted. Per the written report, the treatment plan required administration of 31 milliCuries (mCi) of Y-90 through a catheter via the hepatic artery. During setup, the interventional radiologist (IR) noted a potential air bubble in one of the lines connected to the catheter. The IR disconnected the line and flushed it with solution to clear the air bubble. The IR then activated the SIR-Sphere device without realizing that the line was still disconnected from the catheter. The radioactive material spilled into the sterile 4 inch by 4 inch gauze and drapes on the sterile field. The patient received 13 mCi, which was 42 percent of the prescribed dosage of 31 mCi. The RPM stated that the referring physician and patient were notified and that the patient did not report any side effects as a result of the incorrect dosage administration. Based on CSMC's written report, it was determined that this event required 24-hr notification to the NRC Operations Center. 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. |