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| Start date | Reporting criterion | Title | Event description | System | LER | |
|---|---|---|---|---|---|---|
| ENS 56940 | 30 January 2024 22:50:00 | Agreement State | Agreement State - Y-90 Underdose | The following is a summary of information that was provided by the California Department of Public Health, Radiological Health Branch via email: On January 30, 2024, at 1450 PST, the radiation safety officer of Cedars Sinai Medical Center contacted the Los Angeles County Radiation Management office to report a medical underdose event. The underdose occurred during a treatment of Y-90 (yttrium-90) TheraSpheres microspheres for a radioembolization treatment for liver cancer. The prescribed activity was 480 Gy and the administered activity was 227.6 Gy (about 47 percent of the prescription). The underdose was due to an obstruction of the microcatheter used to deliver the Y-90. The patient has been notified. Cedars Sinai Medical Center will conduct an investigation to gain a better understanding of the details of the event. CA event ID number: 013024 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 56104 | 12 September 2022 07:00:00 | Agreement State | Underdose of Y-90 Microspheres | The following was submitted by the California Department of Public Health by email: On Sept. 12, 2022, the RSO of Cedars Sinai Medical Center (CSMC) contacted Los Angeles County Public Health, Radiation Management (LA County) to report a medical event that ocurred at CSMC. During administraton of Y-90 Theraspheres to a patient, the Y-90 spheres were stuck in the microcatheter and the Authorized User (AU) was unable to administer the full dosage. The dosage drawn in the syringe was approximately 1.77 GBq (48 mCi) but only 1.05 GBq (28 mCi) was administered, a residual dosage of 40.7 percent (not administered). Additionally, the prescribed dose to the target organ, liver, was 124 Gy (12,400 rad). The liver received a dose of approximately 71 Gy (7,100 rad), a difference of 5.3 Gy (5,300 rad). The RSO has initiated an investigation and the AU will be providing a detailed report. California Reference Number: 091222 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 | 7 November 2014 08:00:00 | Agreement State | Agreement State - Medical Event Involving Underdosage to Patient of Y-90 Sir-Spheres | 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. | ||
| ENS 50091 | 30 April 2014 07:00:00 | Agreement State | Agreement State Report - Incorrect Dosage Administered to Patient | 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. |