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 Entered dateEvent description
ENS 505903 November 2014 13:58:00The following information was obtained from the State of Ohio via email: At 12:40 pm (EST) on Nov. 3, 2014, the RSO (Radiation Safety Officer) from the University of Cincinnati Medical Center called the ODH-BRP (Ohio Department of Health - Bureau of Radiation Protection) to report receipt of a contaminated package that exceeded the contamination levels for reporting that occurred that morning. The 300 centimeters squared wipe of the outside of the package yielded 1433 dpm per centimeters squared. The wipe on the inside of the package yielded a contamination rate of 29,244 dpm per centimeters squared. The TI (transportation index) listed on the package was 0.9, and the licensee measured 2.0 at the time of the package receipt. The package was a shipment of two doses of 15 mCi of F-18 FDG with a reference time of 1100 (EST). The receiving licensee has placed the package in storage for radioactive decay. The shipping nuclear pharmacy licensee, PETNET, was notified by the University of Cincinnati Medical Center of the package contamination. The licensee's courier arrived back at the pharmacy for vehicle and personnel contamination (survey) at approximately 1310 (EST). The driver and the vehicle were surveyed and did not have any measurable contamination. Receiving licensee University of Cincinnati Medical Center Ohio license number 02110 31 0001 Cincinnati, OH Shipping licensee PETNET Solutions Ohio license number 02500 31 0001 Cincinnati, OH Ohio event report number 2014-028
ENS 5037215 August 2014 14:53:00The following was received from the State of Ohio via email: The licensee prepared and delivered a therapeutic dose of TheraSpheres to a patient's liver on August 14, 2014. The written directive was for 120 Gy to the liver with 27 mCi of Y-90 TheraSpheres. On August 15, 2014, the licensee discovered that 20% of the dose that was supposed to be administered to the patient was still in the bottom of the vial. Although the licensee prepared the vial in accordance with the manufacturer's instructions, 20% of the TheraSpheres remained in the bottom of the vial and did not go into suspension. The patient and referring physician have been notified. The Bureau (Ohio Bureau of Radiation Protection) will be conducting a follow-up investigation regarding this event. The patient received 96 Gy to the liver instead of the prescribed 120 Gy. Ohio incident # OH140010 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 5002711 April 2014 09:00:00

The following information was received from the State of Ohio via email: The assistant RSO of BP Husky refinery called the Ohio Department of Health Bureau of Radiation Protection (Department) at 0933 EDT on April 10, 2014 to report an incident that happened overnight.

Thermo Fisher had been contracted to remove an old Ohmart gauge for disposal. During the removal of the gauge, the gauge and the gauge rigging fell. The gauge was still attached to the source well and was being removed as a single unit. The damaged gauge fell and became stuck inside the vessel tower skirt. During the fall, the gauge was damaged and the source became exposed. The dose rate from the device is 640 mRem/hr at 1 ft. The area, which is located inside a secured refinery, is roped and barricaded. No personnel were injured during the incident.

The gauge is an Ohmart SHRM-BW. It contained 1000 mCi of Cs-137 when installed in 1966.

The Department sent an inspector to the site to observe the source and gauge recovery efforts on April 10, 2014. VEGA (the successor company of Ohmart) sent a field service representative to provide technical assistance. As of 1830 CDT on April 10, 2014, efforts to return the source to the shielded position were unsuccessful.

The Department continues to monitor efforts to secure the source in a shielded position.

  • * * UPDATE FROM KARL VON AHN TO CHARLES TEAL ON 4/11/14 AT 1556 EDT * * *

At 1530 EDT on April 11, 2014, the BP Husky Refinery RSO called the Department to report that the VEGA and Thermo Fisher service personnel were able to retract the sealed source back into the shielded position. A preliminary check of the sealed source leak tests did not indicate any leakage of the sealed source. Notified R3DO (Pelke) and FSME Events Resource.

ENS 4977027 January 2014 17:05:00The following was received from the State of Ohio via email: On Jan. 27, 2014, the RSO of Flower Hospital provided a telephone report of medical event that occurred on Jan. 24 and 27, 2014. A patient was being treated with a Varian GammaMed Plus HDR with 4.7 Ci of lr-192 in a vaginal cylinder. The written directive was for three fractions of 500 cGy for a total of 1,500 cGy. Then during the delivery of the second fraction the licensee realized that they were only delivering a planned dose of 166 cGy. The licensee completed the second fraction as planned. The treatment planning was entered as one third of the 500 cGy for three fractions instead of three fractions of 500 cGy. The license will modify the treatment plan to give the full prescribed 1500 cGy to the patient. The patient was notified on Jan. 27, 2014. This is a reportable medical event under OAC 3701:1-58-101 (A)(1)(c.) for a fractionated dose that differs by more than 50%. Ohio Report #: OH140001 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 4981511 February 2014 17:37:00During 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 4936620 September 2013 11:58:00The following information was obtained from the State of Ohio via email: At 1000 (EDT) on Sept 20, 2013 the Cleveland Clinic Foundation (CCF) RSO called the Ohio Department of Health (ODH) Bureau of Radiation Protection to report the determination of a medical event based on the back calculations from a symptomatic patient that had received a Y-90 microsphere treatment on May 9, 2013. The patient received a treatment of Y-90 SIR-Spheres to both the left and right lobes of the liver. The vessel to the stomach area was coiled to prevent shunting. At the time of the treatment, the patient complained of some abdominal pain. The post-treatment scan was inconclusive regarding the shunting to the stomach area. The AU (authorized user) and interventional radiologist concluded that a shunt was unlikely. The patient continued to complain of stomach pain and returned to the CCF on Sept 5, 2013 for an endoscopy. The endoscopy revealed ulcers in the potentially affected areas. After additional review of the post-treatment scan by the licensee, it was not abundantly apparent, but possible, that shunting did occur. Based on the assumption that shunting did occur, the licensee determined that the gastric antrum, an unintended treatment area, received a dose of 62 Gy. The ODH Bureau of Radiation will be conducting an onsite investigation. This incident was assigned ODH incident report number 2013-011. NMED Item Number: OH130014 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 4867816 January 2013 16:46:00The following information was provided by the State of Ohio: The Ohio Department of Health Bureau of Radiation Protection was notified by the licensee RSO of a potential medical event. A patient was planned for a vaginal cylinder (HDR) procedure. Approved plan prescribed 4 Gy to target organ (vaginal canal) and 4.61 Gy to rectum. On the first of three fractions, the cylinder was inserted by the Authorized User (AU) in the rectum instead of the vaginal canal. The AU reviewed the film and approved the position for treatment. The physicist determined that the rectum received approximately 6.1 Gy (132% of the prescribed dose). At the time of this report it appears that the intended treatment target received less than 2 Gy (less than 50% of prescribed dose). The device used is a remote afterloader HDR manufactured by Nucletron, Model Microselectron S/N 31472, containing a single sealed source of 4.15 Ci Ir-192. The cause is identified as human error. Item Number: OH130001 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 4859214 December 2012 11:00:00The following information was provided via e-mail from the State of Ohio Bureau of Radiation Protection: At 3:10 PM on Dec 13, 2012 the licensee RSO called the Ohio Department of Health Bureau to report a medical event involving a prostate seed underdose. A prostate seed implant procedure performed on 11/27/2012 was found to have failed the prescribed dose-volume criteria via post-implant CT performed on 12/10/2012. The target prescription was 160 Gy to the prostate. The patient was implanted with 88 Iodine-125 seeds with a total activity of 33.44 mCi (0.38 mCi / seed). The post-implant dosimetry was shown to have a D90 of ~40% of the prescription dose with a number of seeds outside of the prostate. The actual implanted activity in the prostate gland was 27.36 mCi. Sixteen seeds were found in the perineum outside the target volume of the prostate + 1 cm as PTV. The dose to this area unintended to receive radiation was about 20Gy to the periphery of the contour volume containing all the 16 seeds. The physician was informed of the discrepancy on 12/12/2012 and the patient was informed on 12/13/2012. There is no negative impact expected to the patient, the physician indicates. The patient will be re-implanted to correct for the D90 discrepancy. The Bureau of Radiation Protection will be sending an inspector the week of December 17 to investigate the incident." Ohio Report Reference Number: 2012-040 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 4853121 November 2012 17:50:00At 4:45PM on November 21, 2012 the Radiation Safety Officer of the Southern Ohio Medical Center (OH license number 02120 74 0002) located in Portsmouth, OH called the Ohio Department of Health Bureau of Radiation Protection to make a telephone notification of a potential defect with a Nucletron microselectron HDR unit (SN 10281) containing 7.02 Ci of Iridium-192. The following event telephone report was made in accordance with OAC 3701:1-38-23(b)(2) (equivalent to NRC 10 CFR Part 21.xx). The nature of the defect was that prior to initiation of a patient treatment today, the computer console error code indicated a communication problem between the computer console and the HDR unit. The software indicated that the computer system needed to be rebooted which the licensee did. Upon restarting the computer it indicated a delivered treatment time of 24.6 seconds without the licensee initiating the treatment. The licensee did not see the radiation monitor light up, and entered and surveyed the room and patient with a handheld survey instrument. The licensee does not believe that the source left the shielded position. The licensee was able to complete the treatment fraction as planned, which was fraction number ten of ten fractions of 390 seconds. This did not result in a medical event. The Radiation Safety Officer notified their management and the manufacturer. Ohio Event Report Number: 2012-033.
ENS 4809812 July 2012 13:10:00The following information was provided by the Ohio Bureau of Radiation Protection via e-mail: A written directive was given for a patient to receive 115 mCi of Y-90 TheraSpheres microspheres. During the delivery of the microspheres, stasis occurred before the full quantity of the written directive delivered. The licensee did not expect to reach stasis, and will be sending the delivery system to the manufacturer after the remaining Y-90 decays to verify that there was not an equipment malfunction. The licensee calculates that the patient received 68.6 mCi, which is only 60% of the written directive (a 40% underdose). The written directive did not indicate include the phrase 'or until stasis'. The licensee has notified the attending physician. The licensee will be contacting the patient's physician prior to contacting the patient. The licensee states that there are no adverse effects to the patient. No corrective action is planned at this time. Event Discovered: July 11, 2012 at 11:00 am Event Date: July 10, 2012 at 5:00 pm Reporting criteria - medical event OAC 3701:1-58-101(a)(1)(a) 10 CFR 35.3045(a)(1)(i) Ohio Event Report #2012-017 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 475776 January 2012 16:41:00

The following information was received from the State of Ohio via email: The Ohio Department of Health Bureau of Radiation Protection received a preliminary telephone report from the University of Toledo of a device malfunction with a Varian HDR with an Ir-192 source. A patient had received four treatments to the cervix. The physician noticed during examination reddening of the skin on the upper thigh. Upon reviewing the setup with the tandems, a constriction and blockage was identified in the catheters caused by wear debris. It is presumed at the time being that this caused the system to conclude the source had reached the end of the catheter when it had not. Dose calculations are in the process of being reviewed, however the licensee believes that the doses may be less than the quantities for a medical event.

The licensee is The University of Toledo, Ohio license number 02110 49 0006.

The licensee is preparing a written report. The Bureau will be sending an inspector to the site next week. Ohio Report # OH-12-001

  • * * UPDATE FROM KARL VON AHN TO DONALD NORWOOD AT 1101 EST ON 1/13/2012 * * *

The following information was received by email: The Ohio Department of Health, Bureau of Radiation Protection is updating the event report to indicate that this is a medical event.

An Ohio Department of Health Bureau of Radiation Protection inspector investigated the incident at the licensee facility on Thursday Jan. 12, 2012. The Varian HDR (model number AL19000001, SN VS0054) had 4.01 Ci of Ir-192 at the time of the incident and was using the Brachyvision treatment system.

After the fourth of four fractions of 400 cGy each, the attending physician noticed an unusual skin reaction. After licensee was unable to find any errors in the treatment delivered, they began to investigate the hardware. The licensee found a 'corrosion' line in the entry of the Tandem used in the Fletcher Suite Device where the device narrows at is end. During the fourth fraction, apparently the catheter inserted into the tandem snagged on the 'corrosion' causing the starting point of fraction treatment to be misplaced 9 cm. The treatment began from this point, not at the intended treatment site. Preliminary dose calculations were made based on the assumption that the starting dwell position was at this point instead of being fully inserted.

Preliminary dose calculations indicate a skin dose of 1251 cGy to the right thigh, and 1273.9 cGy to the left thigh when no skin dose was intended. The dose to the prescribed treatment point for that fraction was 194.2 cGy instead of 400 cGy. The total dose for all fractions to the prescribed treatment site was 1394.2 cGy instead of the intended 1600 cGy.

The patient and the referring physician have been notified. The physician does not anticipate any adverse effects.

The original catheter used is no longer made by Varian, and the licensee was using a replacement catheter that that is slightly larger in diameter and is thicker than the original. The original catheter did not get caught on the 'corrosion' in the Tandem. This issue was found with two Tandems in three Fletcher Suite Device sets. The new catheter fully inserts as intended into the other Tandems.

The licensee's corrective action includes marking the new catheters to provide a visual indication that it has been fully inserted into the Tandem."

Notified R3DO (Orth) and FSME EO (Turtil).

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 4753520 December 2011 08:14:00At 11:30 AM December 19, 2011, the licensee's radiation safety officer provided a 24-hour telephone report notification of a shutter failure on a gauge. The gauge involved was an Ohmart SH-100, serial number 70230, containing 10 mCi of CS-137, with an assay date of Aug 1981. The shutter mechanism is a lead block screwed to a sliding aluminum plate. The licensee was removing the gauge from its mounting to replace it with a different new gauge as permitted by their license. When the licensee removed the gauge from its mounting, the lead block separated from the aluminum plate. The licensee replaced the lead shielding and secured it in place. The licensee secured the gauge from unauthorized access and will return it to the manufacturer for disposal with other gauges they are replacing. The licensee states that no personnel received radiation doses during this event. Ohio Report #OH110005