Semantic search
| Start date | Reporting criterion | Title | Event description | System | LER | |
|---|---|---|---|---|---|---|
| ENS 55157 | 26 March 2021 18:00:00 | Agreement State | Medical Event Report - Underdosage | The following was received from the Ohio Radioactive Materials Program via email: On Friday March 26, 2021 at approximately 1400 (EDT), a patient was treated with a single dose of Yttrium-90 Theraspheres. Following the procedure, the licensee determined that 76.1 percent of the prescribed dose was delivered to the patient based upon post treatment surveys of the catheter, tubing and other waste. No contamination was detected on the delivery system or in the room post procedure. No staff members were contaminated and there was no harm to the patient. The patient and referring physician were notified. Ohio NMED Report: OH210002 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 53672 | 16 October 2018 04:00:00 | Agreement State | En Revision Imported Date 7/24/2019 | EN Revision Text: AGREEMENT STATE REPORT - ADMINISTERED DOSE LOWER THAN PRESCRIBED DOSE The following information was obtained from the State of Ohio via email: On October 16, 2018, a suspected medical event occurred. A patient was prescribed a dose of 120 Gy for segment 4 of the left lobe of the liver involving Y-90 TheraSpheres. All the pre-procedural safety checks were made and appropriate imaging (cone beam CT) was performed to check the catheter position and lesion location. During the first set of infusions, there was high resistance felt on the syringe which continued for the next few infusions. It was decided to stop the treatment as there was risk of inadequate delivery of the microspheres due to possibility of stasis and concern for non-target embolization to other sites. The residual was calculated and it was noted that estimated dose delivered was 6.4 Gy to the target lesion. Post-procedure, the patient had a PET CT to check the Y-90 microspheres distribution and it did not demonstrate any non-targeted deposition. The administered dose was 6.4 Gy to segment 4 of the left lobe of the liver. The dose was therefore 5% of the prescribed dose, a 95% difference. The microspheres not delivered to the target were contained in the catheter. No contamination occurred as a result of this event. The referring physician has been notified as well as the patient. A follow-up inspection will be conducted during the week of Oct. 22, 2018. Ohio NMED Report No.: OH180010
The following retraction was obtained from the State of Ohio via email: A follow-up inspection was conducted on October 24, 2018 to determine the circumstances leading up to this event. It was determined the difference in administered dose was due to emergent patient conditions and resistance of the patient's complex hepatic arterial system; stasis. There was no evidence of catheter misplacement, non-target disposition or mechanical failure of the Y-90 microsphere delivery system. There was also no evidence of any non-compliance with NRC guidelines or Ohio Administrative Code regulations. Notified R3DO (Norton) and NMSS Events Notification (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 49815 | 24 January 2014 05:00:00 | Agreement State | Agreement State Report - Medical Event Involving Unintended Dose | During a liver radio embolization procedure with Y-90 SIRTEX Sir-Spheres on January 24, 2014 an unanticipated shunting occurred and was identified during the procedure. The procedure for the right liver lobe was stopped when the shunting was identified. The licensee runs contrast between vial doses to verify proper delivery of the microspheres. After imaging of the patient, the licensee determined on January 27, 2014 that the unintended dose to the gastric fundus was 11 Gray. The licensee reported the medical event to ODH BRP (Ohio Department of Health - Bureau of Radiation Protection) by telephone on February 11, 2014 at 3:30pm (EST). The referring physician and patient were notified on January 24, 2014. The patient is asymptomatic (no adverse effects) and is currently receiving medical monitoring. Ohio Report #: OH140002 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 47071 | 12 July 2011 15:00:00 | Agreement State | Agreement State Report - Patient Received Treatment to Incorrect Organ | Approximately four (4) weeks prior to the therapy, patient was scanned for extrahepatic shunting through injection of 99mTc MAA into the hepatic artery per protocol. No shunting to the duodenum was identified. On Tuesday July 12, 2011, at 11:00 AM the patient was treated with 0.977 GBq of 90Y TheraSphere per protocol. Interventional Radiologist properly placed catheter. A second interventional Radiologist confirmed the catheter placement. On Tuesday July 12, 2011 at 6 PM, post procedure scan identified significant activity in the duodenum. Initial estimate indicates 0.117 GBq had shunted into the duodenum approximately 12% of the administered activity. An initial estimate indicates dose to duodenum is approximately 110 Gy. The asymptomatic patient was discharged with follow up contacts for possible intervention as a result of the dose to the duodenum. Patient has been notified. Referring physician has been notified. Literature search indicates patient may have developed vascularization post-scan, pretreatment. An inspector from the Department (Ohio Bureau of Radiation Protection) will conduct an inspection the week of July 25, 2011." Ohio Event Report Number: 2011-014 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.
Based on further review by the licensee, the patient's organ in question did not receive the above referenced dose. Notified the R3DO(Duncan) and FSME (Zelac). | ||
| ENS 46572 | 8 December 2010 05:00:00 | Agreement State | Agreement State Report - Potential Underdose to Patient Due to Aborted Treatment | The following information was received from the State of Ohio by email: Written directive called for Iodine-125 radioactive seed implant of the prostate with 142 seeds, 0.477 mCi each, total activity 67.7 mCi. Transperineal implantation of the needles were attempted on 12/8/10. After placement of four needles (8 sources) in the first (anterior-most) row, it was subsequently noted that patient's pelvic inlet was too narrow for adequate placement of the lateral two columns of seeds after repeated attempts. Authorized User Physician decided to abort procedure at this point. Patient was taken to the recovery room in satisfactory condition. Patient was notified at time of event. Radiation Safety Officer was not notified at time of event. Licensee's RSO discovered event during QMP review on morning of 1/25/11 and notified ODH (Ohio Department of Health) by telephone and e-mail that afternoon. ODH inspector will visit licensee's location on 1/31/11. Given: Radionuclide: I-125; Activity: 3.2 mCi (118.4 MBq); Dose: 81.1 rad (0.811 Gy). Intended: Radionuclide: I-125; Activity: 67.7 mCi (2504.9 MBq); Dose: 14400 rad (144 Gy). The source used was a Brachytherapy sealed source I-125; Model Number STM-1251; Serial Number 2357321SO; Activity .477 Ci (17.649 GBq). Ohio number: OH110001 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 46376 | 29 October 2010 04:00:00 | Agreement State | Agreement State - Dose Delivered to Wrong Organ | The following was received from the state of Ohio via email: Approximately three (3) weeks prior to therapy, the patient was scanned for extra hepatic shunting through injection of Tc-99m MAA into the hepatic artery per protocol. No shunting to the duodenum was identified. On Tuesday, October 26, 2010, at approximately 1455 hours, the patient was treated with 3.959 GBq Y-90 TheraSphere microspheres per protocol. A Interventional Radiologist properly placed catheter, and confirmed by second Interventionist Radiologist. On Tuesday, October 26, 2010, at approximately 1930 hours, a post-procedure scan identified significant activity in the duodenum. Initial estimate indicates dose to duodenum approximately 90 Gy (90 Sv). Patient has been hospitalized at Cleveland Clinic for observation and possible intervention as a result of dose to the duodenum. (The) patient has been notified. (The) referring physician has been notified. (A) literature search indicates patient may have developed vascularization post-scan, pre-treatment. Ohio Report #: OH 2010-060 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 46286 | 27 September 2010 04:00:00 | Agreement State | Ohio Agreement State Report - 95% Medical Underdosage Due to Equipment Failure | The following report was received from the State of Ohio via email: On September 27, 2010, the Gamma Knife gave a Fatal Error and terminated treatment to a patient. The error appears to be a failed computer disc drive. The safety system of the Gamma Knife functioned as designed, moving the patient out of the treatment machine and closing the Gamma Knife doors. The patient was safely removed from the treatment room. A service representative was immediately contacted and repair of the Gamma Knife is in progress. It is intended to give the remaining dose from the plan to the patient once the Gamma Knife is repaired. The device in question is a Leksell, Model Perfexion Gamma Knife unit (S/N MV010), which contains a 13,824 Ci Co-60 source. The intended dose was 1400 rad. The delivered dose was 71.5 rad. The target organ was the brain. There is no effect on the patient. Ohio report #: OH100021.
On 11/9/10 the problem was diagnosed as faulty computer on unit. Computer was replaced and fully tested on 9/28/10. Patient remained in hospital overnight on 9/27/10 and received remainder of treatment on 9/28/10. No adverse effects anticipated due to delay in completing treatment. Licensee has contacted the manufacturer to review this incident for applicability to other units. Ohio Item Number 100021 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 44397 | 7 August 2008 18:00:00 | Agreement State | Agreement State Report - Underexposure During Hdr Medical Treatment Due to Equipment Malfunction | The State received notification of a possible medical event due to an equipment malfunction. The licensee was treating a patient for rectal cancer using an HDR Nucleotron Micro Select Model 105.999 Serial 31776. The prescribed treatment consisted of the administration of 29 catheter doses of Iridium-192. During the 12th catheter dose, an equipment malfunction caused a failure of the administered treatment. The failure mode was Code 200 - "No radiation detected." The failure mode caused the unit to stop treatment by not proceeding to the next catheter. Nucleotron immediately contacted. A service technician is expected to arrive on 8/8/08 for repair of the device. Once the HDR unit is repaired, the treatment plan and written directive will be modified and treatment of the patient resumed. Patient and physician have been advised of the treatment interruption and no adverse impact is expected. The State of Ohio plans to send an inspector to the facility on 8/11/08. 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 40575 | 4 March 2004 21:00:00 | Agreement State | the Cleveland Clinic Foundation Administered an Underdose During a Therapeutic Treatment | During a therapeutic procedure using I-125 Gliasite from 2/28 - 3/1, the state licensee administered an under dose of 24%. The therapist calculated a dwell time of only 97 hours when the prescribed dwell time was 120 hrs for treating a brain tumor. This resulted in the patient receiving 5,300 rads instead of the prescribed 7,000 rads. Both the patient and the referring physician were notified. The licensee will make up for the under dosage by using a linear accelerator. |