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| Start date | Reporting criterion | Title | Event description | System | LER | |
|---|---|---|---|---|---|---|
| ENS 55310 | 15 June 2021 05:00:00 | Agreement State | Medical Event - Underdose | The following was received from the Illinois Emergency Management Agency (the Agency) via email: University of Chicago Medical Center contacted the Agency on the afternoon of 6/15/21 to report a medical underdose of Lu-177 that occurred that day. Although information provided was preliminary, no untoward medical impact is expected to the patient. The Radiation Safety Officer (RSO) for the licensee contacted the Agency at approximately 1615 CDT on June 15, 2021, to report that a patient scheduled to receive 200 mCi of Lu-177, Lutathera therapy for neuroendocrine tumors, received only 68 percent of the dose prescribed (136 mCi) in the written directive. The underdosing was reportedly due to leakage in the adaptor/needle connection. No personnel or area contamination occurred. The licensee is still evaluating whether or not the remaining dose will be delivered at a future date. The RSO confirmed the patient and referring physician were notified within 24 hours. IEMA inspectors will perform a reactive inspection on June 17, 2021. The reporting requirements for the licensee, as specified in 32 Ill. Adm. Code 335.1080(c) were met, and the licensee is aware of the need for a written report within 15 days. This report will be updated once additional details become available on 6/17/21. Item Number: IL210019 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 54019 | 19 April 2019 05:00:00 | Agreement State | Agreement State Report - Lost and Recovered I-125 Source | The following information was obtained from the state of Illinois via email: The RSO (radiation safety officer) at the University of Chicago (Hospital), called to report that the University received one lsoAid, Model IAl-125A, I-125 source for a seed localization procedure. It had an activity of 271 microCuries when implanted in the patient on Thursday, April 18, 2019. On Friday, the patient's tissue (containing the I-125 seed was excised) and sent to pathology for evaluation. During all steps, the individuals involved reported that they measured appropriate dose rates from the seed. The Pathology technician was using scissors on the patient's tissue and the seed popped out of the specimen and fell into the sink. The seed was recovered before it went down the drain. Surveys of the sink show no contamination or dose rate measurements. The radiation safety staff measured the recovered source with both a survey instrument and a gamma counter, and the source has no measureable dose rate. The patient was surveyed and it was determined that the source (was) not in the patient. A review of the SSDR (sealed source and device registry) sheet has determined that this source contains I-125 adsorbed on a silver rod which is further encased in the outer capsule. The outer capsule measures 3.0 mm x 0.5 mm and there are no visible signs that the source was cut. They plan to take the seed for an x-ray today to determine if the inner rod is missing and to see if there are obvious signs that the outer capsule was breached. UPDATE: The I-125 seed was found intact in the sink trap. The source that was initially believed to be the subject seed was from another patient and was a three-year-old prostate seed that had decayed to background. NMED Item Number: IL190012 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 53127 | 15 December 2017 06:00:00 | Agreement State | Agreement State Report - Underdose | The following information was received from the State of Illinois: The University of Chicago Medical Center reported an underdose of Y90 Theraspheres today (12/19/17) to a patient. 53.4 % of dose was delivered with 46.6% stuck in catheter. 21 mCi was ordered and 11.21 was delivered. CT scan verified dose administered in correct location. On 12/18/17, it was still undetermined why remaining dose hung up in catheter. Additional dose (is) being ordered to complete the therapy as a fractionated dose. The licensee is investigating why the catheter became blocked. A 15 day written report will follow. Illinois Incident: IL177059 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 42207 | 12 September 2005 06:00:00 | Agreement State | Illinois Agreement State Report - Medical Misadministration | The State provided the following information via email: On December 14, 2005 the licensee's Radiation Safety Officer, (name deleted), called the Division and forwarded information describing a medical misadministration that involved a brachytherapy dose that was greater than 10 percent from the intended treatment. The misadministration had occurred some months ago. The event was discovered as a result of a review of past treatments during an attempt to understand, what appeared to be, anomalies for certain cases. In a particular case on September 12, 2005, a patient began treatment for cervical cancer with a 'Fletcher Suit' manual brachytherapy afterloader using Cs-137 sealed sources. A transposition error was made in the digitization of the patient's lateral film used to construct the applicator's position and thus the positions of the radiation sources relative to the locations of the dose calculation points. Therefore, the digital locations used for mapping and treatment planning of points 'right A' and 'left A' relative to the sources were incorrectly determined. These calculated points used in the treatment planning were located in a region of lower dose rate within the tumor than the true anatomical 'A points', at which the prescription should have been defined. As a result, the prescription/final treatment plan used incorrect lower dose rate points and called for the use of an erroneously high source loading. Based on a retrospective analysis, instead of the calculated average dose rate of 0.545 Gy/hr for the erroneous 'A points', the actual delivered averaged dose rate to the true 'A points' was 0.74 Gy/hr. This resulted in an average dose of 54.3 Gy delivered to the true points A instead of the planned 40.0 Gy. The dose to the other points, namely rectum and bladder, were calculated correctly because their location did not involve the digitization step in which the transposition error occurred. These doses, which were calculated correctly, were all within acceptable limits. Only the tumor dose was in excess of the intended dose. This event occurred because of a misunderstanding concerning use of the new treatment planning system (TPS) that was being introduced into the clinic. The TPS allows digitizing either a right or left lateral film for locating the sources, bladder and rectal points for calculating doses. However the location of target point 'A', which is used for dose prescription, must be determined manually. Therefore a separate program is used which requires digitizing the source applicator on AP and lateral films to localize these points. In this additional step, the orientation of the lateral film on the digitizer was reversed left to right from what the program required, resulting in sign reversal of the anterior-posterior coordinate of the left and right 'A points'. This error was discovered in December, when looking into why positions of calculated points sometimes appeared unusual. This error was not caught at the time of the original implants. Once this potential source of dose discrepancy was discovered, the licensee reviewed all the patients whose dosimetry plans were determined with the new TPS since treatments were first initiated some three months ago. Three total patients were identified. The magnitude of the effect was found to also depend upon the orientation of the applicator in the patient. Only the case described above had those adverse complications which resulted in a medical event. A review of the two additional dosimetry plans showed that due to the orientation of the apparatus in the patient, the dose to the true prescription point was less than 5% greater than the planned dose. The clinical consequences for the patient concerned in this report are being evaluated by physicians. Four Cs-137 sealed sources with a total activity of 178 mCi were inserted into the patient. The planned averaged point A dose was 40.0 Gy and the actual administered dose was 54.3 Gy. Other than the 'point A' dose, no other dose calculation points were outside of the treatment specifications. The physicians are reviewing the revised dosimetry plans to determine if there will be any increased risk of complications for this patient. The clinical consequences for the patient concerned in this report are being evaluated by physicians. The dose at the various calculation points were: Dose points/Planned Dose (Gy/hr)/Actual Dose (Gy/hr) Right A/0.56/0.74, Left A/0.530.74, Right B/0.18/0.18, Left B/0.17/0.17, r-rectum/0.33/0.37, s-rectum/0.35/0.39, t-rectum/0.31/0.32, u-rectum/0.21/0.21, B-bladder/0.47/0.43. This matter will be included during an pending routine inspection which will be conducted in the next 30 days. Corrective Actions: Action Number / Corrective Action: 1 PROCEDURE MODIFIED 2 PERSONNEL RECEIVED ADDITIONAL TRAINING Patient Information: Patient Number: 1 Patient Informed: N Date Informed: Therapeutic BRACHY, MANUAL AFTERLOADER Organ: CERVIX Dose: 5430 rad 54.3 Gy % Dose Exceeds Prescribed: 36 % Dose is Less Than Prescribed: Effect on Patient: UNKNOWN Administered By: PHYSICIAN Dose to Family: 0 rem 0 Sv Dose to Newborn: 0 rem 0 Sv Dose to Fetus: 0 rem 0 Sv Source of Radiation: Due to the nature of the event, this matter was reported to the U.S. NRC Operations Center on December 15, 2005. It was assigned event number 42207 Source Number: 1 Form of Radioactive: SEALED SOURCE Radionuclide or Voltage (kVp/MeV): CS-137 Source Use: BRACHYTHERAPY Activity: .178 Ci 6.586 GBq Manufacturer: Model Number: Serial Number: Device/Associated Equipment: Device Number: 1 Device Name: MANUAL AFTERLOADER Model Number: Manufacturer: UNKNOWN Serial Number: Reporting Requirement: 32 IAC 335.1080 - Any administration of radioactive materials that results in a 'reportable event' (misadministration), licensee shall notify the agency by telephone NLT next day after licensee ascertains and confirms that a 'reportable event' has occurred. Mode Reported: Written Illinois Item No. IL-050073 |