ENS 56470
ENS Event | |
|---|---|
04:00 Feb 28, 2023 | |
| Title | Dose Misadministration |
| Event Description | The following information was provided by the Maryland Department of the Environment (MDE) via email:
On 04/14/2023 at 0951 [EDT], the MDE discovered an unsigned, undated report from the University of Maryland Medical Center, Baltimore, MD, that a medical misadministration had occurred on 02/28/2023. [After] contacting a health physicist and the Radiation Safety Officer (RSO) [at the University of Maryland], they confirmed that the event had actually occurred. A dose of 104.73 mCi of Ludotadipep [Lu-177] was being administered to a patient as part of a phase 1 clinical trial to treat metastasis. During the procedure, catheter infiltration (catheter movement) occurred resulting in a significant portion of the dose remaining in the upper left arm. The study sponsor was informed. Subsequent gamma scans showed that within 24 to 48 hours5.555556e-4 days <br />0.0133 hours <br />7.936508e-5 weeks <br />1.8264e-5 months <br /> the dose had migrated to the intended treatment site. MDE is following up with the RSO and medical staff to confirm that the actual dose delivered to the treatment site was within 20 percent of the dose prescribed in the written directive. The University of Maryland staff has determined that an unintended dose estimated at 157 Rem had been delivered to the upper arm tissue. As of 04/14/2023, no ill effects have been observed, and the patient has been scheduled to resume subsequent treatment. This event is being reported under 10CFR 35.3045 (a)(1)(ii) B `. a dose that exceeds 50 Rem to an organ or tissue from administration of a radioactive drug containing byproduct material by the wrong route of administration'.
The following information was provided by the Maryland Department of the Environment (MDE) via email: [The MDE] has been informed that the NRC medical team has reviewed this event notification and determined that this is not a reportable event under 10 CFR 35.3045. The medical team determined that, although not explicitly named as such, this event notification describes an extravasation. Extravasations are currently exempted from medical event reporting due to Commission policy, however this may change in the near future. Please note that the NRC does not consider extravasations as 'wrong route of administration,' as stated in 10 CFR 35.3045(a)(1)(ii)(B). On May 19, 2023, the patient's physician at [University of Maryland Baltimore] (UMB) confirmed to [the MDE] that this event can be considered as an extravasation. Notified R1DO (Jackson), NMSS (Rivera), and NMSS Events Notification via 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 | |
|---|---|
| Univ. Of Maryland Medical Center Baltimore, Maryland (NRC Region 1) | |
| License number: | MD-07-014-01 |
| Organization: | Maryland Dept Of The Environment |
| Reporting | |
| Agreement State | |
| Time - Person (Reporting Time:+1095.48 h45.645 days <br />6.521 weeks <br />1.501 months <br />) | |
| Opened: | Paul Kovach 18:29 Apr 14, 2023 |
| NRC Officer: | Ernest West |
| Last Updated: | May 23, 2023 |
| 56470 - NRC Website | |
Univ. Of Maryland Medical Center with Agreement State | |
WEEKMONTHYEARENS 564702023-02-28T04:00:00028 February 2023 04:00:00
[Table view]Agreement State Dose Misadministration 2023-02-28T04:00:00 | |