ENS 53672
ENS Event | |
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04:00 Oct 16, 2018 | |
Title | En Revision Imported Date 7/24/2019 |
Event Description | 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. |
Where | |
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Cleveland Clinic Foundation Cleveland, Ohio (NRC Region 3) | |
License number: | 02110180013 |
Organization: | Ohio Bureau Of Radiation Protection |
Reporting | |
Agreement State | |
Time - Person (Reporting Time:+57.13 h2.38 days <br />0.34 weeks <br />0.0783 months <br />) | |
Opened: | Michael Rubadue 13:08 Oct 18, 2018 |
NRC Officer: | Andrew Waugh |
Last Updated: | Jul 23, 2019 |
53672 - NRC Website | |
Cleveland Clinic Foundation with Agreement State | |
WEEKMONTHYEARENS 551572021-03-26T18:00:00026 March 2021 18:00:00
[Table view]Agreement State Medical Event Report - Underdosage ENS 536722018-10-16T04:00:00016 October 2018 04:00:00 Agreement State En Revision Imported Date 7/24/2019 ENS 498152014-01-24T05:00:00024 January 2014 05:00:00 Agreement State Agreement State Report - Medical Event Involving Unintended Dose ENS 470712011-07-12T15:00:00012 July 2011 15:00:00 Agreement State Agreement State Report - Patient Received Treatment to Incorrect Organ ENS 465722010-12-08T05:00:0008 December 2010 05:00:00 Agreement State Agreement State Report - Potential Underdose to Patient Due to Aborted Treatment ENS 463762010-10-29T04:00:00029 October 2010 04:00:00 Agreement State Agreement State - Dose Delivered to Wrong Organ ENS 462862010-09-27T04:00:00027 September 2010 04:00:00 Agreement State Ohio Agreement State Report - 95% Medical Underdosage Due to Equipment Failure ENS 443972008-08-07T18:00:0007 August 2008 18:00:00 Agreement State Agreement State Report - Underexposure During Hdr Medical Treatment Due to Equipment Malfunction ENS 405752004-03-04T21:00:0004 March 2004 21:00:00 Agreement State the Cleveland Clinic Foundation Administered an Underdose During a Therapeutic Treatment 2021-03-26T18:00:00 | |