Semantic search
| Start date | Reporting criterion | Title | Event description | System | LER | |
|---|---|---|---|---|---|---|
| ENS 45727 | 21 January 2010 05:00:00 | Agreement State | Agreement State Report - Brachytherapy Implants Outside of the Intended Treatment Area | The following information was received via fax: Notifications: The licensee called the PaDEP Southeast Regional Office on the morning of February 25, 2010 to provide a 24-hour verbal notice of a possible Medical Event. The SERO and Central Office discussed the known facts around noon time, and understood the U Penn RSO would be providing more information via email. DEP also provided a verbal notice to NRC Region 1 regarding this possible ME on 2-25-2010. On January 21, 2010 a patient was treated by brachytherapy for prostate cancer with sixty five (65) iodine-125 (I-125) seeds. The I-125 seeds were implanted using real time dosimetry under ultrasonic guidance. The written directive called for a therapeutic radiation dose of 145 gray (Gy) (14,500 rad) to the prostate volume, plus 5 millimeters of margin, using interoperative planning. On February 23, 2010, the patient returned for a 30 day post-implant CT. The scan showed that the implanted seeds were "in an appropriate pattern," but outside the intended target. On February 24th the licensee's Radiation Oncology group determined that an additional quality assurance review was warranted, but the RSO should notify PaDEP/BRP (Pennsylvania Department of Environmental Protection/Bureau of Radiation Protection) regarding the case. Based on the information known at this time, PaDEP/BRP believes this ME is reportable under 10CFR35.3045, and may be an Abnormal Occurrence (AO). The state will perform a reactive inspection next week, and coordinate with NRC Region I; because of their ongoing evaluation of pre-April 2008 brachytherapy implants at U Penn, and at the Philadelphia VA hospital. Cause of the event: A new ultrasound unit that was used to place the I-125 seeds may have been malfunctioning. Actions: There is a reactive inspection scheduled to investigate this apparent ME at U Penn on March 2, 2010. PaDEP/BRP will also ask U Penn to evaluate the need for FDA notification regarding the ultrasound unit. Event Report ID Number: PA100002 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 46101 | 7 July 2010 04:00:00 | Agreement State | Agreement State Report - Delivered Dose Differed from the Prescribed Dose by Greater than 50% | The following was received via fax from the Pennsylvania Department of Environmental Protection: On July 7, 2010 a patient was beginning the first of three vaginal treatment fractions with an Ir-192 HDR. It was discovered on July 14, 2010 that the end of the treatment tube was placed 3.5 cm short of its intended location. When the patient returned for the second treatment, she was imaged again, and staff noticed the treatment tube was in a different location from the previous treatment. Licensee estimates that, for the first fraction, the intended treatment volume received only about 10% of the intended dose for that fraction. Per 10CFR35.3045(a)(1)(iii), it is required for the licensee to report any event in which the fractionated dose delivered differs from the prescribed dose, for a single fraction, by 50% or more. It is believed the medical staff mis-identified the treatment location and the end of the treatment tube was placed 3.5cm short of its intended location. The licensee is considering making up this dose by adding a fourth treatment fraction. There is no anticipated adverse effect to the patient. There is a PaDEP/BRP reactive inspection scheduled to investigate this ME at U Penn. The patient and the referring physician were notified. A follow-up written report from the licensee is expected. PA Report # PA100015
The following was received via fax from the Pennsylvania Department of Environmental Protection: Due to further information received from the licensee, an amendment is being made to the original sent July 16, 2010, the CAUSE OF THE EVENT has been modified to reflect updated information. Event Description: On July 7, 2010 a patient was beginning the first of three vaginal treatment fractions with an Ir-192 HDR. It was discovered on July 14, 2010 that the end of the treatment tube was placed 3.5 cm short of its intended location. When the patient returned for the second treatment, she was imaged again, and staff noticed the treatment tube was in a different location from the previous treatment. Licensee estimates that, for the first fraction, the intended treatment volume received only about 10% of the intended dose for that fraction. Per 10CFR35.3045(a)(1)(iii), it is required for the licensee to report any event in which the fractionated dose delivered differs from the prescribed dose, for a single fraction, by 50% or more. CAUSE OF THE EVENT: The applicator was placed correctly by the medical staff as confirmed by MRI but moved 3.5 cm short of its intended location prior to treatment. The licensee is considering making up this dose by adding a fourth treatment fraction. There is no anticipated adverse effect to the patient. ACTION: There is a PaDEP/BRP reactive inspection scheduled to investigate this ME at U Penn. The patient and the referring physician were notified. A follow-up written report from the licensee is expected. Notified R1DO (Doerflein) and FSME EO (Villamar). 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 47435 | 10 November 2011 12:00:00 | Agreement State | Agreement State Report - Underdosage of Theraspheres | |||
| ENS 47763 | 20 March 2012 04:00:00 | Agreement State | Agreement State Report - Underdose During Liver Disease Treatment | Event type: A medical event (ME) involving the administration of Yittrium-90 SIR-Spheres which is reportable under 10 CFR 35.3045(a)(1)(i). Notifications: On March 21,2012, the Department's (Pennsylvania Department of Environmental Protection, Bureau of Radiation Protection) Southeast Regional Office received notification via a phone call about this ME. Event Description: The patient was being treated for disease of the liver and received 77% of the intended dose. CAUSE OF THE EVENT: Currently under investigation and unknown at this time. ACTIONS: No harm to the patient is expected. The treating physician notified the patient. The Department (Pennsylvania Department of Environmental Protection, Bureau of Radiation Protection) plans to do a reactive inspection. PA Event Report ID: PA120009. 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.
Notifications: On March 21, 2012, the Department's Southeast Regional Office received notification via a phone call about this ME. After the HOO notification was made the Department was informed that the measurement for actual dose delivered was repeated two times, both indicating the administration was within acceptable limits. Event Description: The patient was being treated for disease of the liver and was initially thought to have received 77% of the intended dose, however after additional measurements were made the dosage delivered was determined to be 81.2% and 82.2%. ACTIONS: Medical Event is being retracted. Notified the R1DO (Newport) and FSME EO (McIntosh). | ||
| ENS 48137 | 26 July 2012 04:00:00 | Agreement State | Agreement State Report - Medical Event Involving an Underdose with Yttrium-90 Spheres | Event Type: A medical event (ME) involving the administration of yttrium-90 SIR-Spheres which is reportable under 10 CFR 35.3045(a)(1)(i). Notifications: On July 25, 2012, the Department's Southeast Regional Office received notification via telephone about this event. Event Description: The patient received 77% of the intended dose. Cause of the Event: Currently under investigation and unknown at this time. Actions: No harm to the patient is expected. The Department (PA Bureau of Radiation Protection) plans to do a reactive inspection. Updates will be provided upon receipt of information. 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 48229 | 23 August 2012 04:00:00 | Agreement State | Agreement State Report - Patient Underexposure Using Yttrium-90 Sir-Spheres Treatment | The following event was received from the Pennsylvania Bureau of Radiation Protection via facsimile: Event type: A medical event (ME) involving the administration of yttrium-90 SIR-Spheres which is reportable under 10 CFR 35.3045(a)(1)(i). Notifications: On August 24,2012, the Department's Southeast Regional Office received notification via a phone call and follow-up electronic correspondence about this ME. Event Description: The patient was being treated for disease of the liver and received 71% of the intended dose as identified by post treatment measurements. The treating physician, who also is the referring physician, notified the patient. Cause of the Event: Currently under investigation and unknown at this time. Actions: No harm to the patient is expected. The Department plans to do a reactive inspection PA Report Number: 120026 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 48303 | 11 September 2012 04:00:00 | Agreement State | Agreement State Report - Patient Underexposure Using Yttrium-90 Sir-Spheres Treatment | The following event was received from the Commonwealth of Pennsylvania via facsimile: Event type: A medical event (ME) involving the administration of yttrium-90 SIR-Spheres which is reportable under 10 CFR 35.3045(a)(1)(i). Notifications: On September 12, 2012, an inspector was performing a reactive inspection for a recent event (PA120026) that occurred on August 23, 2012. During the inspection the licensee reported another similar Sir-Sphere event. Event Description: A patient was being treated for disease of the liver with 33.04 millicuries (mCi) of Y-90 and received 25.6 mCi resulting in 77.5% of the intended dose. The treating physician, who also is the referring physician, notified the patient. Cause of the Event: Currently under investigation and unknown at this time. Actions: No harm to the patient is expected. The Department's reactive inspection occurring on September 11, 2012 incorporated this new event and therefore no new inspection is planned. PA Report Number: 120030 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 52457 | 20 December 2016 05:00:00 | Agreement State | Agreement State Report - Medical Underdose | The following report was received via fax: On December 20, 2016, a leak occurred during an administration of Yttrium-90 (Y-90) TheraSpheres to a patient, resulting in less than 80% of the prescribed dosage being administered. A total of about 8.99 millicurie of Y-90 activity was administered; or 34.6% of the prescribed 25.95 mCi activity. The prescribed dose was 17,470 rad (174.7 gray), with the leak resulting in a dose to the patient's liver of about 6,040 rad (60.4 Gy). The leak also caused contamination of the administration area, which was immediately and successfully decontaminated. As an under-dose, no immediate harmful effect to the patient resulted from the event. The referring physician and patient were made aware of the event during the procedure. Pennsylvania event: PA-160040 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 52504 | 19 January 2017 05:00:00 | Agreement State | Agreement State Report - Received Dose Less than Prescribed Dose | The following is excerpted from an email: On January 20, 2017 the licensee informed the Department (Pennsylvania Department of Environmental Protection Bureau of Radiation Protection) of an under dose incident involving yttrium-90 (Y-90) TheraSpheres. It is reportable as per 10 CFR 35.3045(a)(1)(i). On January 19, 2017 a patient underwent a Y-90 TheraSphere treatment. The staff reported the procedure went as planned; however, upon surveying the waste and performing a dose calculation it was found that the patient received approximately 29% of the prescribed dose. The patient was notified of this under dose on January 20, 2017. The physician utilized contrast medium to view the flow prior to the procedure and no issues were seen. No increased resistance was noted and the physician was able to flush the line post administration. The manufacturer was notified and will be conducting a joint investigation with the hospital staff. No harm is expected to the patient. A reactive inspection is planned by the Department. More information will be provided upon receipt. PA Event Report ID No: PA 170001 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 53430 | 25 May 2018 04:00:00 | Agreement State | En Revision Imported Date 10/15/2018 | EN Revision Text: AGREEMENT STATE REPORT - PATIENT SKIN CONTAMINATION The following was received from the Commonwealth of Pennsylvania via email: On May 29, 2018, the Department's (Bureau of Radiation Protection) staff in Central Office became aware of a medical event (ME) at U PENN hospital in Philadelphia. The ME is reportable as per 10 CFR 35.3045(a)(1)(i) and also meets criteria for an Abnormal Occurrence. On May 25, 2018, a 17 year old pediatric patient underwent an 834 millicurie metaiodobenzylguanidine (MIBG) lodine-131 (I-131) treatment for brain cancer. The dose was delivered in a 30 ml syringe and infused via an automatic pump. The nuclear medical technician present during the infusion reported seeing a small amount of blood, but other than that, nothing unusual was noted. However, upon completion of the infusion, meter readings noted high activities on the patient's clothing and bed linen. The possible reason given being a faulty connection line on the automatic pump. The contamination is believed to have also been present on the skin all weekend. Due to the large dose of I-131 infused, the licensee's staff were not able to see the contamination on the patient's skin until he developed erythema. The licensee is in the process of doing a dose reconstruction for the skin contamination. Based on the reading from the patient and estimated activity in the various contaminated items, the licensee currently estimates that approximately 50% of the intended dosage was successfully infused. The authorized user has been informed and is currently notifying the patient's parents and the referring physician. A reactive inspection is planned by the Department. More information will be provided upon receipt. PA Event Report ID No: PA 180012 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.
The University of Pennsylvania (U Penn) reported that a patient's skin became contaminated during medical treatment on 5/25/2018. The 17-year-old pediatric patient was scheduled to receive 30.86 GBq (834 mCi) of I-131 metaiodobenzylguanidine (MIBG) for treatment of brain cancer. The dosage was delivered in a 30 ml syringe and infused via an automatic pump. The nuclear medicine technician present during the infusion saw a small amount of blood, but nothing unusual other than that was noted. However, upon completion of the infusion, radiation surveys revealed high activities of I-131 on the patient's clothing and bed linen. U Penn stated that the patient's upper right thigh was cleaned. On 5/27/2018, the patient reported discomfort and reddening (i.e. erythema) on the skin of his upper right thigh, which developed into a lesion and further into desquamation (grade 3) the next day. Radioactive contamination is believed to have been present on the patient's skin for 24 to 48 hours. Based on U Penn measurements, nuclear medicine imaging, and the patient's clinical symptoms, the dose to the skin was estimated to be between 50,000 and 120,000 cGy (rad) to a 15 cm2 area. Radiation safety staff consulted with U.S. DOE's REAC/TS in Oak Ridge TN, to verify dose calculations. Calculations of the activity in the waste and the exposure rate from the patient in previous treatments estimated the activity delivered at 15.54 GBq (420 mCi). It was calculated that approximately 7.77 GBq (210 mCi) went to the waste. The cause of the incident is believed to be a faulty connection line on the automatic pump. The patient was also disconnected from the infusion pump at the 'Spiros tube' to use the lavatory part way through the procedure. Due to the large dosage of I-131 infused, U Penn staff were unable to detect the contamination on the patient's skin until he developed erythema. The authorized user was informed and notified the patient's parents and referring physician. Pennsylvania DEP, Bureau of Radiation Protection, performed a reactive inspection on 6/7 and 6/13/2018. U Penn is conducting a full root cause analysis to develop and implement corrective actions. Procedures that have already been implemented for I-131 MIBG patients included placing absorbent chucks between all parts of the infusion line and the patient's body and requiring an authorized user to be contacted for approval if it is necessary to disconnect a patient during the infusion. Root Cause(s): possible equipment failure, training, and/or human error in connecting the line to the infusion pump. Actions: A reactive inspection has been completed by the Department. More information will be provided upon receipt from U Penn. Notified R1DO (Bower), NMSS Events Notification E-mail Group, and INES Coordinator (Milligan).
The following update was received from the Commonwealth via fax: Licensee has provided additional information; Corrective Actions include: A complete evaluation is being performed of the infusion system used for this treatment to identify any deficiencies, including comparison of CT imaging of the Spiros connection used in this treatment and an unused one. A multidisciplinary I-131 MIBG team with representatives from Nuclear Medicine, Radiation Safety, Nursing and Oncology has been established. The team will meet regularly to review and update policies and procedures for I-131 MIBG therapies. Some immediate steps have included: (1) use of absorbent material under the administration line over the patient's body, (2) a change to the administration procedure to require that the infusion not be stopped unless medically necessary and determined by the Authorized User, (3) planned implementation of continuous patient observation during administration including evaluation of the use of portable video monitoring, (4) a new procedure has been implemented to address patient fluid management prior to and during infusion, (5) a review of the infusion system has commenced with focus on the Spiros connector, including additional training on their use. Patient specific decontamination procedures have been developed for each treatment treated since the incident. Since decontamination procedures must take into account the patient's age and medical condition, it has been necessary that the medical staff have major input into the procedures for these patients. The knowledge gained from the patient-specific decontamination procedures will be used to refine the decontamination SOP. For therapeutic doses in which an activity on the skin that would result in desquamation can be two thousandths of a percent of the dose. It is important to be able to make measurements in these difficult environments. Testing has begun to determine the capabilities of systems that might be used to measure betas in environments in which gammas are several orders of magnitude more abundant than betas. Radiation Safety incident response procedures have been revised to include a time out and immediate involvement of additional Health Physics staff during incidents, including during possible Medical Events. The procedure is aimed at refocusing the attention of Health Physicists on all aspects of the incident response, and to prevent the Medical Event reporting requirements from distracting attention from other aspects of the response. CAUSE OF THE EVENT: a) A leak in the system caused by a failure of the Spiros connection in the infusion line. b) Policies and procedures relating to I-131 MIBG dose administration lacked coordination and oversight. SOPs have been managed separately by each Department (Nursing, Nuclear Medicine, Oncology, and EHRS). c) Policies and procedures relating to patient contamination and decontamination during dose administration were incomplete. ACTIONS: A reactive inspection has been completed by the Department. Notified R1DO (Cahill), NMSS Events Notification (email), and INES Coordinator (Milligan).
The following was received from the Commonwealth of Pennsylvania via email: UPDATE 3, clarifications: The written directive prescribed 30.23 GBq (817 mCi) of I-131. The dosage administered measured 30.86 GBq (834 mCi) and was delivered over the course of 90 minutes. The estimated activity delivered to the correct treatment site was determined to be 22.68 GBq (613 mCi), not 15.54 GBq (420 mCi) as previously reported. No decontamination of the patient (right upper thigh) was performed at the time the contamination of bed linens and pants was discovered. This wasn't completed until signs of erythema were present. PA Event Report ID No: PA 180012 NRC Item# 180252 Notified R1DO (Dentel), and NMSS Events Notification and INES Coordinator (Milligan) via email. | ||
| ENS 54964 | 20 October 2020 04:00:00 | Agreement State | Missing Licensed Material | The following information was received from the Commonwealth of Pennsylvania via email: On October 20, 2020 the licensee discovered a lost gadolinium-153 source. This source, Eckert and Ziegler Model NES8412, is an attenuation correction source in a SPECT camera. These sources are sold in pairs, and the serial numbers for the pair are R3-129 and R3-130. Only one is missing and it is unknown which it is currently. The licensee believes the sources were present in mid-June when the source holders were removed from the gamma camera in preparation for scrapping. The licensee is investigating to confirm that is true. The sources were nominally 250 mCi (+20%/-10%) each on March 1, 2019. The activity on June 15, 2020 was calculated to be 64 mCi, and on the date of discovery 44 mCi. The licensee has notified its facility and safety staff and is actively searching for the source. The DEP (Department of Environmental Protection) has been in contact with the licensee and will update this event as soon as more information is provided. PA incident no.: PA200022 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 55337 | 2 July 2021 04:00:00 | Agreement State | Patient Under Dose | The following was received via an email from the state of Pennsylvania: The Department (PA Bureau of Radiation Protection) received notification from a licensee on July 2, 2021 of a medical event involving a Y-90 TheraSphere. The licensee noted 71 percent of the prescribed dose of 30.8 millicuries was administered to the patient. A mechanical blockage occurred in the delivery system preventing spheres from exiting the administration vial. All material was contained in the delivery system, lines, and patient. Area monitoring confirmed that no leak occurred and no contamination of the work area. Nuclear Medicine imaging of the waste confirmed activity concentrated within the vial. The physician and patient have been notified. No adverse effects to the patient are anticipated. The Department is currently in contact with the licensee and will update this event as soon as more information is provided. Pennsylvania Event Report ID No: PA210006 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 55851 | 18 April 2022 04:00:00 | Agreement State | Patient Underdose | The following was received from the Pennsylvania Bureau of Radiation Protection by e-mail: On April 18, 2022, a patient underwent a Y-90 SIR-Sphere treatment. The prescribed dosage was 7.07 milliCuries, however only 5.27 milliCuries was able to be delivered, or 74.5 percent. The apparent cause is that the blood vessel the catheter was placed in had a complicated vasculature which inhibited the flow of the spheres. No harm is expected to the patient. The referring physician and the patient have been informed. Event Report ID Number: PA220014 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 55889 | 4 May 2022 04:00:00 | Agreement State | Underdose | The following information was provided by the Pennsylvania Department of Environmental Protection, Bureau of Radiation Protection (Department) via fax: On May 6, 2022, the University of Pennsylvania informed the Department of an underdose incident on May 4, 2022, involving yttrium-90 (Y90) SIR-Spheres. A patient underwent a Y90 SIR-Sphere treatment and the catheter placement changed during a SIR-Spheres administration and the Authorized User intentionally stopped the administration as continuing could have resulted in harm to the patient. The administered activity was 67 percent of the prescribed activity (15.1 mCi vs 22.51 mCi). The Department will perform a reactive inspection and is currently in contact with the University of Pennsylvania. The event will be updated this as soon as more information is provided. It is reportable as per 10 CFR 35.3045(a)(1)(i). Pennsylvania Report Number: PA220017 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 56661 | 5 August 2023 15:07:00 | Agreement State | Medical Underdose | The following information was provided by the PA Bureau of Radiation Protection (the Department) via email: On August 4, 2023, the licensee, University of Pennsylvania, informed the Department of an under-dose incident involving yttrium-90 (Y-90) TheraSpheres. The event is reportable per 10 CFR 35.3045(a)(1). On August 3, 2023, it was determined that 71.0 percent of the prescribed dose to the target tissue was delivered for the above treatment. The only information relayed to the Department so far was that there were no spills or leaks in the system. The DEP (Department of Environmental Protection) is currently in contact with the licensee and will update this event as soon as more information is provided. The cause of the event is unknown at this time. The Department will perform a reactive inspection. More information will be provided as received. Event Report ID No: PA230021
An administration of Y-90 TheraSpheres occurred with no apparent difficulties. No leaks or spills were identified, as corroborated by post administration monitoring which identified no contamination. However, when the waste was measured it was determined that less than 80 percent (72.6 percent) of the prescribed activity was administered. It is estimated that 21.18 mCi of the 29.18 mCi prescribed dose was administered. The patient and prescribing physician have been informed. No adverse effects to the patient are present nor are any anticipated. Notified R1DO (Dimitriadis) and NMSS (Email). 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 57081 | 17 April 2024 04:00:00 | Agreement State | Medical Underdose | The following information was provided by the Pennsylvania Department of Environmental Protection Bureau of Radiation Protection (the Department) email: On April 18, 2024, the licensee informed the Department of a medical event. It is reportable per 10 CFR 35.3045. On April 17, 2024, a patient was receiving an iodine-131 (sodium iodine solution) treatment. The patient was prescribed 100 mCi of I-131. However, the patient received only 5 mCi of I-131. At this time no other information is available. The Department will update this event as soon as more information is provided. The Department will perform a reactive inspection. More information will be provided upon receipt. PA Event Number: PA240006 A Medical Event may indicate potential problems in a medical facilitys use of radioactive materials. It does not necessarily result in harm to the patient. | ||
| ENS 57084 | 28 December 2022 04:00:00 | Agreement State | Medical Event | The following information was provided by the Pennsylvania Department of Environmental Protection Bureau of Radiation Protection (the Department) via email: On April 19, 2024, the licensee informed the Department of a medical event. It is reportable per 10 CFR 35.3045. On April 19, 2024, the licensee discovered a medical event from December 28, 2022. A patient received a diagnostic scan that was performed using 1 mCi of I-131. This scan was performed without a written directive being prepared. Immediately upon discovery, the authorized users and technologists received training to remind them that they are required to verify the prescribed dosage to be administered against a prepared written directive. The licensees system was modified to remind the employees to verify the prescribed dosage in the written directive against the dosage about to be administered. No harm is expected to the patient. At this time, no other information is available. The Department will update this event as soon as more information is provided.
The following information was provided by the Pennsylvania Department of Environmental Protection Bureau of Radiation Protection (the Department) via email: The Department wishes to retract this event as it does not meet the qualifications for reporting. Notified R1DO (Werkheiser) and NMSS Events Notification via email. PA Event Number: PA240008 A Medical Event may indicate potential problems in a medical facilitys use of radioactive materials. It does not necessarily result in harm to the patient. | ||
| ENS 57085 | 29 December 2022 04:00:00 | Agreement State | Medical Event | The following information was provided by the Pennsylvania Department of Environmental Protection Bureau of Radiation Protection (the Department) via email: On April 19, 2024, the licensee informed the Department of a medical event. It is reportable per 10 CFR 35.3045. On April 19, 2024, the licensee discovered a medical event from December 29, 2022. A patient received a diagnostic scan that was performed using 1 mCi of I-131. This scan was performed without a written directive being prepared. Immediately upon discovery, the authorized users and technologists received training to remind them that they are required to verify the prescribed dosage to be administered against a prepared written directive. The licensees system was modified to remind the employees to verify the prescribed dosage in the written directive against the dosage about to be administered. No harm is expected to the patient. At this time, no other information is available. The Department will update this event as soon as more information is provided.
The following information was provided by the Pennsylvania Department of Environmental Protection Bureau of Radiation Protection (the Department) via email: The Department wishes to retract this event as it does not meet the qualifications for reporting. Notified R1DO (Werkheiser) and NMSS Events Notification via email. PA Event Number: PA240009 A Medical Event may indicate potential problems in a medical facilitys use of radioactive materials. It does not necessarily result in harm to the patient. | ||
| ENS 57086 | 31 January 2023 04:00:00 | Agreement State | Medical Event | The following information was provided by the Pennsylvania Department of Environmental Protection Bureau of Radiation Protection (the Department) via email: On April 19, 2024, the licensee informed the Department of a medical event. It is reportable per 10 CFR 35.3045. On April 19, 2024, the licensee discovered a medical event from January 31, 2023. A patient received a diagnostic scan that was performed using 4 mCi of I-131. This scan was performed without a written directive being prepared. Immediately upon discovery, the authorized users and technologists received training to remind them that they are required to verify the prescribed dosage to be administered against a prepared written directive. The licensees system was modified to remind the employees to verify the prescribed dosage in the written directive against the dosage about to be administered. No harm is expected to the patient. At this time, no other information is available. The Department will update this event as soon as more information is provided.
The following information was provided by the Pennsylvania Department of Environmental Protection Bureau of Radiation Protection (the Department) via email: The Department wishes to retract this event as it does not meet the qualifications for reporting. Notified R1DO (Werkheiser) and NMSS Events Notification via email. PA Event Number: PA240010 A Medical Event may indicate potential problems in a medical facilitys use of radioactive materials. It does not necessarily result in harm to the patient. |