ENS 52580
ENS Event | |
|---|---|
05:00 Feb 24, 2017 | |
| Title | Agreement State Report - Medical Event Due to High Dose |
| Event Description | The following information was supplied via email from the State of North Carolina:
On 2/27/2017 the North Carolina Radiation Protection Section (RPS) received the following notification from Duke University Medical Center, License number 0247-4. A possible Medical Event occurred at Duke University Medical Center on February 24, 2017 involving Y-90 microspheres during a liver embolization procedure. Duke personnel reported to North Carolina Radiation Protection Section (RPS) on February 27, 2017 of the event meeting the reporting requirements for a Medical Event as dictated in NRC Licensing Guidance, Rev. 9 under: Medical Event [ME] Reporting: The licensee shall commit to report any event, except for an event that results from intervention of a patient or human research subject, in which: the total dose or activity administered differs from the prescribed dose or activity, as documented in the written directive, by 20 percent or more, except when stasis or emergent patient conditions are documented and resulted in a total dose or activity administered that was less than that prescribed; At this time, the details provided by Duke University Medical Center for this ME are as follows: Delivered dose was 94 percent higher than the prescribed dose in the Written Directive to the treatment site. The apparent cause appears to be an error in reading the prescribed radioactivity (in GBq) before converting to the administered activity (in mCi), indicating operator error that occurred in the radio pharmacy at Duke University Medical Center. RPS has dispatched an investigator to perform a reactive inspection at Duke University Medical Center. This investigation is ongoing and RPS will have additional information to complete this report. The State on North Carolina does not know if the patient has been notified of the received dose being higher than the prescribed dose. 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 | |
|---|---|
| Duke University Medical Center Durham, North Carolina (NRC Region 1) | |
| License number: | 0247-4 |
| Organization: | Nc Div Of Radiation Protection |
| Reporting | |
| Agreement State | |
| Time - Person (Reporting Time:+105.62 h4.401 days <br />0.629 weeks <br />0.145 months <br />) | |
| Opened: | Travis Cartoski 14:37 Feb 28, 2017 |
| NRC Officer: | Jeff Rotton |
| Last Updated: | Feb 28, 2017 |
| 52580 - NRC Website | |
Duke University Medical Center with Agreement State | |
WEEKMONTHYEARENS 562542022-12-01T05:00:0001 December 2022 05:00:00
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