ENS 55947
ENS Event | |
|---|---|
05:00 Jun 14, 2022 | |
| Title | Dose Misadministration |
| Event Description | The following information was received from the Minnesota Department of Health (MDH) via email:
We (MDH) received an initial report on 6/15/22 at 1515 CDT of a reportable medical event. The event occurred at the University of Minnesota, license number 1049, in Minneapolis on 6/14/22. The event involved a treatment with Y-90 SirSpheres where 2.2 GBq was ordered but a 5.1 GBq unit dose was delivered and administered. The licensee is working through dose calculations. No additional details are available at this time. Follow up information will be sent when it becomes available. 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.
The normal procedure for this therapy is to order a dose from the manufacturer a couple of weeks prior to the treatment so the radiopharmacy has the material on hand. The dosage ordered from the manufacturer is limited to few vial activities (want to make sure there will be enough for the therapy), and the actual dose to administer to the patient is drawn up by the pharmacy the day of the procedure. The pharmacy delivers the patient dose to the nuclear medicine department. Nuclear Medicine will check the activity compared to the shipping paper to make sure it is within range. They will also do the pre-measurements for determining the residual after the treatment. They will write the activity on the top of the Nalgene jar and bring it to interventional radiology. Interventional radiology will verify the dose on the lid and perform the administration. The residual is determined from the waste in the Nalgene jar per the standard microsphere procedure. The written directive is signed by the authorized user once the residual and actual dose given is determined. In the case on June 14, 2022, there was a communication error between the radiopharmacy (Jubilant) and the person ordering the dose. The pharmacy verified and the person who ordered the dose confirmed the dose was 5.6 GBq (the entire vial amount from the manufacturer). After drawing the dose, the activity in the vial the pharmacy sent was 5.1 GBq (they are not able to draw 100% of the material). Once received in nuclear medicine, the nuclear medicine technologist did their process, including comparing the dose in the vial with the shipping papers from the pharmacy (not the dose prescribed). The dose was brought to interventional radiology for the administration. The interventional radiologist did not see the activity on the Nalgene jar and was unaware that the activity was on the label. Without verifying the activity the interventional radiologist administered the dose. After the procedure the residual was calculated and it was determined that 5.1 GBq was administered (139 mCi prescribed and 137 mCi administered). The Authorized User signed the written directive after the procedure with the 139 mCi prescribed and 137 mCi administered activity. The prescribing physician (interventional radiologist) realized the error the next day when reading the post report. The State performed an on-site investigation and is pursuing enforcement actions. The event is still open. Minnesota will continue to keep NRC informed of the status of the investigation. Notified R3DO (Lafranzo) and NMSS (Rivera-Cappella) |
| Where | |
|---|---|
| University Of Minnesota Minneapolis, Minnesota (NRC Region 3) | |
| License number: | 1049 |
| Organization: | Minnesota Department Of Health |
| Reporting | |
| Agreement State | |
| Time - Person (Reporting Time:+53.32 h2.222 days <br />0.317 weeks <br />0.073 months <br />) | |
| Opened: | Sherrie Flaherty 10:19 Jun 16, 2022 |
| NRC Officer: | Brian Lin |
| Last Updated: | Jul 6, 2022 |
| 55947 - NRC Website | |
University Of Minnesota with Agreement State | |
WEEKMONTHYEARENS 559472022-06-14T05:00:00014 June 2022 05:00:00
[Table view]Agreement State Dose Misadministration ENS 491022012-08-22T05:00:00022 August 2012 05:00:00 Agreement State Agreement State Report - Potential Medical Overdose ENS 475282011-12-07T01:00:0007 December 2011 01:00:00 Agreement State Agreement State Report - Possible Medical Event ENS 460152010-06-15T17:15:00015 June 2010 17:15:00 Agreement State Agreement State Report - Gamma Knife Treatment Administered to Wrong Location 2022-06-14T05:00:00 | |