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| Start date | Reporting criterion | Title | Event description | System | LER | |
|---|---|---|---|---|---|---|
| ENS 55084 | 25 January 2021 08:00:00 | Agreement State | Incorrect Dose Delivered to Patient | The following information was received from the state of California via email: On January 25, 2021, the Radiation Safety Officers (RSO) discovered and reported to CDPH (California Department of Public Health) that a medical event had occurred on December 28, 2020. The RSO stated that during a routine review of the past month's radiation therapies, they discovered that a Y-90 Nordion TheraSphere treatment performed on 12/28/2020 resulted in a delivered dose that was approximately 33 percent greater than the physician's written directive (550 Gy) signed on 12/15/2020. This higher patient dose was the result of administering the dose on Monday (12/28/2020) that was calibrated for administration on Tuesday (12/29/2020). The licensee will be submitting their 15 day report per 10 CFR 35.3045. California report no.: 012521 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 52890 | 4 August 2017 07:00:00 | Agreement State | Agreement State Report - Y-90 Treatment Underdose | The following information was provided by the State of California via email: The RSO (Radiation Safety Officer) of Loma Linda Medical Center notified the RHB (Radiologic Health Branch) Brea ICE (Inspection, Compliance and Enforcement) office on August 7, 2017, that a medical event occurred on Friday, August 4, 2017. A patient was admitted to the hospital for treatment of liver carcinoma. The treatment plan involved use of Nordion model TheraSpheres (Y-90 glass microspheres manual brachytherapy) for radio-embolism to the right lobe of the liver. The patient's written directive called for aggregate treatment of 121Gy (5.241 GBq) of Y-90 to the right lobe target area, but only 9.7 Gy (0.420 GBq) was delivered. The overall percent delivery to target tissue was 8.1%. The patient's lung dose from shunting was 1.01 Gy at 4.8% lung shunting factor. The patient and referring physician were informed of the event on 8/4/2017. The medical event is still being investigated, but is thought that a slow injection flowrate may have caused sedimentation of the microspheres in the delivery system. After a few days for decay, a more intensive review of the delivery system will be conducted. CA 5010 Number: 080417 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 51973 | 27 May 2016 07:00:00 | Agreement State | Agreement State Report - Brachytherapy Underdose | The following was received from the State of California via email: The RSO (Radiation Safety Officer) of Loma Linda Medical Center notified the RHB (Radiologic Health Branch) Brea ICE (Inspection, Compliance and Enforcement) office that they believe a medical event occurred on Friday, May 28, 2016. A patient was admitted to the hospital for treatment of carcinoma. The treatment plan involved (10 CFR) 35.400 use of Cs-137 sealed sources for brachytherapy with a tandem and ovoid applicator. The patient's written directive called for 3,460 cGy to target area A (left side tandem), but only approximately 1,500 cGy was delivered. The lower rectum and vaginal areas received more than expected dose, but is believed to be within tolerance. Critical organs of bladder and mid-rectum also received less than expected incidental exposure. The cause of the under dose was human error. The applicator tube used to place the source into the tandem had become crimped by the lead pig during transport to the patients room. During application by the resident physician and medical physicist, the resistance felt during the application process lead them to believe the source was fully deployed to the end of the tube. The chief physicist notified the RSO on Tuesday, May 31, 2016 at 1630 pm, of his dose calculations, in which the hospital began medical event notifications. 5010 Number: 060216 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 48389 | 23 May 2012 07:00:00 | Agreement State | Agreement State Report - Potential Medical Event | The following was received from the State of California: During a routine inspection on Oct. 8, 2012, RHB inspectors discovered a potential medical event had occurred on May 23, 2012. A patient was admitted to the hospital for carcinoma treatment of the endometrium near both ovaries on May 22, 2012 and treatment began at 1800 PDT. The treatment plan called for 3000 cGy to each ovary, using two 18.5 mg Ra eq. CS-137 sources and an ovoid applicator. (The) dosimetrist placed one source at a time into an insert, which was to be verified by the physician, a second year medical resident, who then placed the insert into the applicator and patient. The source inserts are individually screwed into the ovoid applicator, which prevents the source from movement. The patient treatment was to take 26.5 hrs. On May 23, 2012 at 2030, (the doctor) and the dosimetrist were removing the implant from the patient, starting with the right side. That source was verified to be in the insert and then placed into the pig. The doctor then proceeded to remove the left side insert, which was handed to the dosimetrist, who found the insert to be empty. The radiation survey meter was used immediately around the patient, rolling her back and forth as it appeared the source may be on the bed somewhere. The source was found on an IV monitor stand, which was approx. 2 foot from the patients head partially blocked by a portable lead shield that had been placed the day before. The source recovery was completed around 2045. Hospital staff (supervising MD, lead dosimetrist and RSO) were notified of the event and the patient treatment of the left side was completed on May 29, 2012, after revising the original patient treatment plan. The investigation did not discover how the source ended up on the IV stand. The licensee's RSO evaluated the event and did not feel that it qualified as a medical event per 10CFR35.3045 and therefore did not inform RHB within the 24 hour timeframe. 5010 #: 052312 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 40594 | 16 March 2004 08:00:00 | Agreement State | Agreement State Report - Missing Sr-90 Eye Applicator Source | Licensee reported to Radiologic Health Branch-Granada Hills (RHB-GH) that it had discovered one of its Sr-90 eye applicator sources (Model Manning #357, SIN pending) missing yesterday (03/16/04) from its sealed source storage C-container where it had been stored for the last ten years. The actual eye applicator was kept in its own box provided by the manufacturer. The discovery was made when the RSO was conducting a routine check for leak test/inventory purposes. This source was reportedly last accounted for about July 2003. The original assay date for the source was 8/22/79 at 31.7 millicuries (Reported to be about 17 millicuries now). The source was stored in a locked and alarmed C-container used exclusively for radioactive material storage. A fence around it is also locked. There was no sign of a break-in. However, the licensee reported that in May 2002 there was a break-in to this storage container. The same source was at that time removed from the C-container by the intruder apparently and was later found in an outside barrel so it was recovered. Incidentally, some uranyl nitrate (or acetate?) in microcurie quantities was stolen then, too. The licensee will continue searching to determine the likely disposition of the missing source. RHB-GH suggested they notify their security people. The licensee will be providing a written report. |