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| Start date | Reporting criterion | Title | Event description | System | LER | |
|---|---|---|---|---|---|---|
| ENS 53071 | 6 November 2017 05:00:00 | Agreement State | Agreement State Report - Dose Greater than 50 Rem Delivered at a Site Not Intended for Treatment | The following report was received from the Ohio Department of Health via email: On Friday, November 10, 2017, ODH (Ohio Department of Health) received notification that a cancer patient may have received a dose greater than 50 rem at a site not intended for treatment. A follow-up call was made on Monday November 13, 2017. The licensee stated they believe the Elekta Flexitron (model 136149A02) remote afterloader software package used an incorrect catheter model during the first treatment fraction. The error was discovered while preparing the second fraction. ODH will be sending an inspector to investigate the event this week. See licensee initial description below: A patient was planned to be treated with HDR (High Dose Rate) brachytherapy for GYN (Gynocology) cancer with three fractions. The HDR treatment was planned with a single curved catheters through a Tandem and Cylinder. A dosimetrist preformed a CT based treatment plan for the first fraction. During planning, the dosimetrist did not digitize the catheter correctly. A physicist checked the HDR plan in a hurry and failed to detect the incorrect reconstructed catheter shape in the planning software. During the treatment delivery, the delivery system translated the incorrectly reconstructed catheter as a linear catheter, resulting in the treatment length from the intended 9.0 cm to 15.7 cm. On the second fraction, a new plan was created based on the CT of the day. The dosimetrist did the digitization correctly this time. During the planning check (a routine process), the physicist noticed the differences between the two plans and discovered the error on the first fraction treatment. Remote afterloader HDR Device: ELEKTA Model Number: 136149A02 Sealed Source Brachytherapy Source: IR-192 Model Number: 136147 Ohio Event Number: OH170008 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 51980 | 26 April 2016 04:00:00 | Agreement State | Agreement State Report - Missing Source | The following information was received by the State of Ohio via email: On 4/26/2016, Physics reported that during prepping a return shipment the dosimetrist discovered one I-125 prostate seed was missing from the lead pig. The lead pig contained loose/broken seeds from the implant performed on 4/6/2016. There were three seeds in the vial where there should've been four. The RSO interviewed the dosimetrist and the physicist who worked this case. Inventory log and loading summary were audited. Inventory log recorded 28 seeds returned to storage. Of the 28 seeds returned, 24 were in the cartridge and 4 were loose/broken seeds stored in the lead pig. It was not until 4/26/2016 when Physics discovered only 3 seeds were in the lead pig. Radiation surveys records were audited. Surveys were performed accordingly and readings were background level. At this time, the seed has not been located. Based on the information provided by the medical physicist and the dosimetrist, it is still unclear as to precisely determine when and how the seed became missing. Licensee believes there was no radiation exposure to the individual(s) involved. To prevent a recurrence, two individuals shall visually count the seeds in the lead pig before leaving the operating room. Furthermore, two individuals shall review loading summary to confirm all seeds are accounted for. Licensee has previously observed that 1-125 seeds are prone to static buildup and have the tendency to cling to plastic, glass walls, and other surfaces. Most likely, the lost seed was swept up and discarded with normal trash. Based on the relatively low activity and low energy of the 1-125 seed and measured background readings in the operating room, there was no radiation exposure to workers or members of the public due to this loss. Source/Radioactive Material: Sealed source brachytherapy Manufacturer: Theragenics Model Number: AgX100 Radionuclide: I-125, 0.000396 Ci Ohio Item Number: OH160007 THIS MATERIAL EVENT CONTAINS A "LESS THAN CAT 3" LEVEL OF RADIOACTIVE MATERIAL Sources that are "Less than IAEA Category 3 sources," are either sources that are very unlikely to cause permanent injury to individuals or contain a very small amount of radioactive material that would not cause any permanent injury. Some of these sources, such as moisture density gauges or thickness gauges that are Category 4, the amount of unshielded radioactive material, if not safely managed or securely protected, could possibly - although it is unlikely - temporarily injure someone who handled it or were otherwise in contact with it, or who were close to it for a period of many weeks. For additional information go to http://www-pub.iaea.org/MTCD/publications/PDF/Pub1227_web.pdf | ||
| ENS 51979 | 21 April 2016 04:00:00 | Agreement State | Agreement State Report - Missing Source | The following information was received by the State of Ohio via email: On 4/21/2016 in OR (Operating Room) 11, during seed loading, the dosimetrist noticed that one seed was missing from the transferring stylet as he was transferring the seeds to the loading needle. He immediately notified the physicist in the room. The physicist then checked the sterile area around the cartridge with a survey meter and picked up radiation reading by the luer - lock hub of the cartridge. The physicist assumed that the source had fallen in the sterile towel under the cartridge and determined loading should continue, and they will retrieve the dislodged seed after all needles have been loaded. After all needles were loaded and while implantation was still in progress the physicist and the dosimetrist went to retrieve the dislodged seed but they were not able to locate it. They resurveyed the spot where it was and there was no radiation detected. The physicist emptied the cartridge to verify the number of seeds remaining in the cartridge and the count was as stated in the loading summary. The dislodged seed was missing. To prevent a recurrence, surgical drapes will be used to cover the area under and around the cartridge/loading area instead of sterile hand towels. This would make it easier to identify any seed that may have fallen out during loading. Loose/broken seed(s) will be placed in the lead pig immediately. If there is a dislodged/loose seed that could not be recovered immediately, the physicist will ensure that everyone leaving the room is surveyed. Licensee has previously observed that I-125 seeds are prone to static buildup and have the tendency to cling to plastic, glass walls, and other surfaces. Most likely, the lost seed was swept up and discarded with normal trash. Based on the relatively low activity and low energy of the I-125 seed and measured background readings in the operating room, there was no radiation exposure to personnel or members of the public due to this loss. Source/Radioactive Material: Sealed source brachytherapy Manufacturer: Theragenics Model Number: AgX100 Radionuclide: I-125, 0.000382 Ci Ohio Item Number: OH160006 THIS MATERIAL EVENT CONTAINS A "LESS THAN CAT 3" LEVEL OF RADIOACTIVE MATERIAL Sources that are "Less than IAEA Category 3 sources," are either sources that are very unlikely to cause permanent injury to individuals or contain a very small amount of radioactive material that would not cause any permanent injury. Some of these sources, such as moisture density gauges or thickness gauges that are Category 4, the amount of unshielded radioactive material, if not safely managed or securely protected, could possibly - although it is unlikely - temporarily injure someone who handled it or were otherwise in contact with it, or who were close to it for a period of many weeks. For additional information go to http://www-pub.iaea.org/MTCD/publications/PDF/Pub1227_web.pdf | ||
| ENS 48839 | 19 March 2013 04:00:00 | Agreement State | Agreement State Report - Y-90 Sir-Sphere Under Dose of 87% | The licensee notified the Department (Ohio Department of Health) on March 20, 2013 of a medical event that occurred on March 19, 2013 involving a Y-90 SIR-Sphere patient treatment. The delivery system became clogged and delivered only 3.2 mCi (13%) of the 24.3 mCi prescribed activity. The cause of the event is under investigation. The licensee plans on retreating the patient. Ohio Item Number: OH130002 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 48678 | 15 January 2013 05:00:00 | Agreement State | Agreement State Report - Misplacement of Brachytherapy Source During Medical Treatment | The following information was provided by the State of Ohio: The Ohio Department of Health Bureau of Radiation Protection was notified by the licensee RSO of a potential medical event. A patient was planned for a vaginal cylinder (HDR) procedure. Approved plan prescribed 4 Gy to target organ (vaginal canal) and 4.61 Gy to rectum. On the first of three fractions, the cylinder was inserted by the Authorized User (AU) in the rectum instead of the vaginal canal. The AU reviewed the film and approved the position for treatment. The physicist determined that the rectum received approximately 6.1 Gy (132% of the prescribed dose). At the time of this report it appears that the intended treatment target received less than 2 Gy (less than 50% of prescribed dose). The device used is a remote afterloader HDR manufactured by Nucletron, Model Microselectron S/N 31472, containing a single sealed source of 4.15 Ci Ir-192. The cause is identified as human error. Item Number: OH130001 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 43192 | 27 September 2006 05:00:00 | Agreement State | Agreement State Report - Potential Medical Event | At 1405 EST on 02/26/07, the state received a report via the US Mail from Akron General Medical Center. On 09/27/06 a patient was receiving a 10 fraction dose for Mammo-site Breast Brachytherapy using a HDR afterloader with a total prescribed dose of 3400 RAD. A problem with the PLATO planning computer digitized the breast image using an incorrect treatment factor which doubled the fractional dose. The same total prescribed dose was delivered but in 5 vice 10 fractional doses. The patient was made aware of the error on 09/27/06. Tissue necrosis was observed due to the procedure, but it is being evaluated if any additional necrosis occurred due to the delivery of the total dose in 5 fractions vice the 10 planned fractional doses. The licensee is taking corrective action to prevent a reoccurrence of this type of error.
This event has been reviewed and determined to be a reportable medical event.
The State provided the following update to this report via facsimile: On September 28, 2006, the licensee notified the ODH Bureau of Radiation protection that they had an event which did not meet the reporting requirement of a medical event but they were revising their HDR program to prevent a recurrence. The Bureau requested a report that was received on February 26, 2006. The patient was to receive a total dose of 3400 rad total dose through 10 fractions of 340 rad each. The patient received 5 fractions of 680 rad for a total dose of 3400 rad. Upon review of the report it was determined by consultation with NRC Region 3 that a medical event did occur because 'Prescribed Dose' for remote afterloaders includes Total Dose and Fractionated dose. The reason for the event was the Physicist entered the wrong planning film magnification into the treatment system. The patient has experienced some tissue necrosis at the treatment site, although some necrosis is expected with this therapy (MammoSite). The necrosis may have been exacerbated by the dosage scheme. The patient is being followed by her attending physician. The patient and attending physician were notified on 09/27/2006. The Bureau conducted an inspection on November 2, 2006 and identified problems with the licensee's HDR program an additional inspection will be conducted during the week of March 5, 2007. The R3DO (Lanksbury) and FSME EO (Morell) were notified. Ohio Report OH2007-11 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 42729 | 10 July 2006 04:00:00 | Agreement State | Agreement State Report - Medical Overdose | The following information was provided by the state related to prostate brachytherapy which was performed on 7/10/2006 using I-125 seeds. Prostate seed implant plans are specified in kerma units (U) by default in our computer planning system. However, the ordering of seeds is specified in mCi (milliCuries). In this instance the default seed strength was not changed to mCi and a plan was developed for (the patient) to receive 111 seeds of an activity of 0.394 U per seed when 0.394 mCi was desired. The order form was completed for 111 seeds of the expected (not planned) activity of 0.394 mCi per seed. The result was an implant with seeds of activity 27% higher than planned. The overdose was noticed by the hospital on 7/12/2006. The physician, the patient, and the State of Ohio were notified on 7/13/2006. The State inspected the facility on 7/18/2006. |