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| Start date | Reporting criterion | Title | Event description | System | LER | |
|---|---|---|---|---|---|---|
| ENS 55152 | 12 June 2019 04:00:00 | Agreement State | Failure to Report Underdose to Patient | The following was received from the state of Ohio via email: During a routine inspection an unreported medical event (that occurred in 2019) involving Yttrium-90 'SirSpheres' was discovered. During patient treatment the licensee encountered increasing resistance to the delivery of the microspheres, leading the licensee to believe the patient had reached stasis. After further investigation the licensee determined the cause of the resistance was clogging of the microcatheter. The dose delivered to the patient was 79.2 percent of the prescribed dose. A subsequent treatment was given to the patient to make up for the underdose. At the time the licensee's procedures did not consider this as a reportable event. The reportable event procedures have been updated. Ohio Item Number: OH210001 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 51233 | 14 July 2015 14:30:00 | Agreement State | Agreement State Report - Dose to Improper Treatment Site | The following information was received by the State of Ohio via email: On July 14, 2015, the licensee reported that the intended delivery of Y-90 SirSpheres went to the small bowel instead of the right lobe of the liver during a procedure that morning. The intervention physician felt that the dose delivery was not going where it should be going and discontinued the treatment. Scanning the patient identified that the Y-90 microspheres were delivered to the small bowel. The original prescribed dose to the right lobe of the liver was 78 Gy with 20.5 mCi. The delivered dose of 36 Gy with 7.79 mCi went to the small bowel instead of the liver right lobe. The patient was notified at the time of the event. The interventional physician was the referring physician and AU (Authorized User). Ohio Report: OH150007 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 44973 | 15 December 2008 04:00:00 | Agreement State | Incident Involving Co-60 Gamma Knife During Patient Treatment | The following information was provided by the state via e-mail: During an inspection on March 17 through 19, 2009, the ODH (Ohio Department of Health) inspector identified through the licensee's radiation safety committee meeting minutes an incident involving the Co-60 Gamma Knife that occurred on December 15, 2008, at approximately 2:15 pm. During a patient treatment, the couch moved out of treatment position. The emergency stop button was activated and the system did not respond. The licensee's staff had to manually pull out the couch from the Gamma Knife and manually close the doors to the Gamma Knife to shield the source. According to the licensee, radiation exposure to all individuals involved with the incident was minimal. The incident DID NOT result in a medical event for the patient. The manufacturer (Elekta) was immediately contacted and the Gamma Knife was repaired. Patient treatment was resumed and completed without incident. According to Elekta, the Gamma Knife system experienced an illegal couch sensor error due to a known software bug problem. The licensee failed to notify the Ohio Department of Health, Bureau of Radiation Protection of this device failure and therefore this is determined to be non-compliant with the provisions of rule 3701:1-40-20 (B)(2)(a,b,c) of the Ohio Administrative Code. Ohio State Reference Number: OH 2009-008 |