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| Entered date | Event description | |
|---|---|---|
| ENS 54876 | 3 September 2020 11:13:00 | The following was received from the Ohio Department of Health: The licensee tried to perform a split dose procedure on the right lobe anterior and right lobe posterior portion of a patient's liver. The prescribed dose was 60 mCi Y-90 Theraspheres (approximately 150 Gy) for each site. The posterior was treated first and then the catheter was moved to the anterior position. Post treatment scans of the patient indicated the posterior received 20 mCi (35 Gy) and the anterior received 100 mCi (180 Gy). The physician believes the catheter slipped after initial placement, resulting in an overdose to the anterior and underdose to the posterior. The licensee will no longer conduct spilt dose procedures. Ohio Item Number: OH200006 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 53071 | 14 November 2017 16:17:00 | 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 53011 | 13 October 2017 13:45:00 | The following information was received from the State of Ohio via email: On 10/12/17 during an infusion of Y-90 SIRSpheres that began at 11:05 a.m. (EDT), the treatment device malfunctioned and ceased delivery of the radioisotope, resulting in an under-dosing of the patient's liver. No contamination of the facilities or personnel was detected. All activity that was not delivered into the patient was placed back into the acrylic box and secured in the nuclear medicine hot lab for decay. A SIRSpheres representative was present during the treatment, but the cause of the malfunction is not known at this time. Once sufficient decay of the radioisotope has occurred, the delivery device will be shipped to SIRSpheres for technical analysis and root cause determination. The patient was informed on the day of the event. Ohio Item Number: OH170006 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. |