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| Start date | Reporting criterion | Title | Event description | System | LER | |
|---|---|---|---|---|---|---|
| ENS 57222 | 10 July 2024 04:00:00 | Agreement State | Y-90 Underdose | The following is a summary of information provided by the New Jersey Department of Environmental Protection (NJDEP) via email: Kennedy Memorial Hospital University Medical Center (the licensee) was scheduled to administer a Nordion TheraSphere therapy (116 mCi of Y-90) to a patient. The target organ was the right hepatic lobe of the liver. There was a tubing failure in the delivery system and the administration was suspended. It is estimated that only 2.62 mCi (17 percent) of the prescribed dosage was administered. The patient and referring physician were notified. The patient has been re-scheduled for treatment. No release of licensed material or contamination was reported. The licensee will follow-up with a full written report. The licensee is sending the equipment that failed to the manufacturer for detailed analysis. 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 43039 | 8 December 2006 05:00:00 | 10 CFR 35.3045(a)(1) | Shift of I-125 Seeds After Implantation | On 10/26/06 the licensee implanted a patient with 104 seeds of I-125 (total activity of 42.2 millicuries, manufactured by Bard, Inc.) to treat prostate cancer. The post implant CT performed on 12/08/06 indicated that the distribution of the seeds was inferior to the intended distribution. A percentage of the seeds had shifted approximately 1.5 cm inferior to what was intended. The licensee is still evaluating at this time what percentage of the seeds intended for the prostate were no longer in the prostate . The licensee immediately informed the patient and the prescribing physician. The patient has to this point shown no ill effects from the migration. However, a quantity of the seeds have migrated to the perineum. Due to the unknown quantity of seeds in the perineum the licensee is still investigating the amount of dose received in this area. The licensee is investigating the cause of the migration. After the cause is determined they will put corrective actions in place to prevent reoccurrence. The licensee has performed multiple implants that were close to 100% successful since this occurrence. The licensee intends to supplement the patients treatment with an external bean in order to achieve the intended dose. The licensee notified NRC Region 1 (S. Gabriel, P. Lanzisera)
Based on discussion with NRC Region 1 (S. Gabriel), the licensee provided the following revision to the initial event report: On October 25, 2006, the licensee implanted 104 I-125 seeds into a patient for the treatment of prostate cancer. The total activity of the implanted seeds was 42.4 mCi. A post-implant CT performed on December 8, 2006, indicated that the seed were misplaced approximately 1.5 cm inferior to the intended position. The licensee is still evaluating the details of the post-implant dosimetry. Notifications pursuant to 10 CFR 35.3045 were made on December 8, 2006. The licensee is still evaluating the cause of the misplacement of the iodine seeds. After the cause(s) has been determined, corrective actions will be put in place. The patient will require will require further treatment of the prostate gland. External beam therapy will be used to supplement the dose to prostate. R1DO (Conte) and NMSS EO (Morell) notified. 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. |