ENS 41763
ENS Event | |
|---|---|
04:00 Jun 10, 2005 | |
| Title | Fractional Dose Delivered Differed from the Prescribed Dose |
| Event Description | A hyperthyroid therapy patient received one of the intended two Nal-131 capsules sent by the radio pharmacy for the therapy. The patient received 10.2 mCi in one capsule instead of the intended 20.6 mCi in two capsules. Both capsules were received in one plastic vial inside of a lead shield. The entire vial was assayed and the assay of 20.6 mCi was within 10% of the prescribed dose of 20.0 mCi. The technologist failed to notice that there were two capsules in the vial because a desiccant inside the vial blocked the view of the second capsule and prevented the second capsule from leaving the vial. Normally, hyperthyroid therapy doses are received in one capsule. Therefore, the technologist was not expecting a second capsule.
The radio pharmacy discovered the second capsule when the package was returned to the pharmacy the next day, June 10, 2005. They called the Nuclear Medicine department at 8:30 am on June 10, 2005. The prescribing physician was called and he requested that the patient receive the second capsule. The patient returned to the Nuclear Medicine department at 10:00 am on June 10, 2005 and received the second capsule, which assayed at 9.74 mCi at that time. The total dose the patient received was 19.94 mCi. Why the event occurred: Hyperthyroid therapy doses are normally received in one capsule. The technologist was not expecting a second capsule. The desiccant placed in the vial by the radio pharmacy obscured the second capsule from the technologist's sight. The desiccant also prevented the second capsule from coming out of the vial when the first capsule came out of the vial. Effect on the patient: The prescribing physician does not believe this event will have a negative effect on the patient as she received the remainder of the dose within 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br />. To prevent recurrence of this action the licensee will assay all applicable capsule vials after the patient has received their dose, but before the patient leaves the department. This will ensure that no capsules remain in the vial. Certification that the licensee notified the individual: The patient was notified by telephone on June 10, 2005 and the patient returned to the hospital to receive the second capsule of 9.74 mCi Nal-131.
Based on a re-reading of Part 35 and a conversation with Region 3 Materials Inspection and Materials Licensing Branches it was determined that this is not a medical event and should be retracted. Notified Reg 3 RDO (Patrick Louden) and NMSS (Patricia Holahan).
Through discussions with Region 3, the licensee was informed that the NRC has determined this event is, in fact, a medical event therefore should not be retracted. Notified R3DO (Burgess) and NMSS (Michelle Burgess). |
| Where | |
|---|---|
| Edward W. Sparrow Regional Center Lansing, Michigan (NRC Region 3) | |
| License number: | 21-01430-01 |
| Organization: | Edward W. Sparrow Regional Center |
| Reporting | |
| 10 CFR 35.3045(a)(1) | |
| Time - Person (Reporting Time:+10.12 h0.422 days <br />0.0602 weeks <br />0.0139 months <br />) | |
| Opened: | Tracy Maudrie 14:07 Jun 10, 2005 |
| NRC Officer: | John Knoke |
| Last Updated: | Jun 22, 2005 |
| 41763 - NRC Website | |
Edward W. Sparrow Regional Center with 10 CFR 35.3045(a)(1) | |
WEEKMONTHYEARENS 417632005-06-10T04:00:00010 June 2005 04:00:00
[Table view]10 CFR 35.3045(a)(1) Fractional Dose Delivered Differed from the Prescribed Dose 2005-06-10T04:00:00 | |