ENS 45034
ENS Event | |
|---|---|
17:30 Apr 29, 2009 | |
| Title | Medical Event Involving an Underdosage During Treatment for Liver Cancer |
| Event Description | At approximately 1:30 pm, on April 29, 2009 a medical event occurred at Indiana University Medical Center, NRC License No. 13-02752-03. This medical event involved the treatment of a patient with Y-90 microspheres (Nordion TheraSpheres). A dosage of 61.3 mCi was prescribed by the Authorized User. TheraSpheres are provided as a unit dosage and said dosage was assayed at 12:15 pm (4/29/09) to contain 60.1 mCi. Based upon a radiation monitoring device affixed to the TheraSphere delivery system, the pre-treatment reading was 7 milliroentgens per hour (mR/hr). Following the administration of the microspheres and four subsequent flushings of the delivery system, the radiation monitor exhibited a reading of 2 mR/hr, indicating that approximately 28.6% (17.2 mCi) of the dosage remained in the delivery system. When the subsequent flushing failed to reduce the remaining activity in the system, an independent measurement of the residual activity was performed to confirm that the entire dosage had not been delivered as prescribed.
The vendor (Nordion) was notified of this event earlier today (4/29/09). Based upon discussions with their technical representatives, it is their opinion that the residual microspheres may be attached to the septum of the dose vial. For future treatments, the vendor representative suggested that the dose vial be given a good shake during the check-in and assay procedure to help dislodge any microspheres that may have adhered to the vial septum during shipment. They also suggested that during the administration process if the residual dosage appears to be present in the dose vial, tilting and tapping the dose vial and/or the acrylic box containing the dose vial may dislodge any microspheres that may adhere to the vial septum. These suggestions are being incorporated into the written procedures for TheraSphere treatments. The Radiation Safety Office attempted to perform some radiation measurements of the delivery system to determine the location of the residual activity. Due to the relatively high exposure rates from the residual radioactivity in the delivery system, it was not possible to definitively determine the distribution of the residual activity in the system at this time, mainly due to the potential for contamination and elevated radiation levels to RSO staff. More thorough evaluations may be possible once the radioactivity in the system diminishes due to radioactive decay. Notification of the referring physician of the occurrence of this medical event was made at 10:25 am today (4/30/09). The patient's wife was notified of the occurrence of the medical event at 10:30 am today. 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 | |
|---|---|
| Indiana University Medical Center Indianapolis, Indiana (NRC Region 3) | |
| License number: | 13-02752-03 |
| Organization: | Indiana University Medical Center |
| Reporting | |
| 10 CFR 35.3045(a)(1) | |
| Time - Person (Reporting Time:+21.35 h0.89 days <br />0.127 weeks <br />0.0292 months <br />) | |
| Opened: | Mack Richard 14:51 Apr 30, 2009 |
| NRC Officer: | Donald Norwood |
| Last Updated: | Apr 30, 2009 |
| 45034 - NRC Website | |
Indiana University Medical Center with 10 CFR 35.3045(a)(1) | |
WEEKMONTHYEARENS 509832015-04-14T14:00:00014 April 2015 14:00:00
[Table view]10 CFR 35.3045(a)(1) Y-90 Microsphere Dose Less than Prescribed ENS 495422013-11-14T18:50:00014 November 2013 18:50:00 10 CFR 35.3045(a)(1) Y-90 Microshpere Dose Less than Prescribed ENS 477222011-07-05T05:00:0005 July 2011 05:00:00 10 CFR 35.3045(a)(1) Medical Event - Dosage Delivered to Patient Differed by 20% from Prescribed Dosage ENS 450342009-04-29T17:30:00029 April 2009 17:30:00 10 CFR 35.3045(a)(1) Medical Event Involving an Underdosage During Treatment for Liver Cancer ENS 436302007-09-10T15:20:00010 September 2007 15:20:00 10 CFR 35.3045(a)(1) Medical Event - Patient Received an Underdose of Yttrium-90 ENS 424532006-03-29T21:30:00029 March 2006 21:30:00 10 CFR 35.3045(a)(1) Different Length Bucket and Applicator Used During Brachytherapy Dose ENS 424692005-01-17T18:00:00017 January 2005 18:00:00 10 CFR 35.3045(a)(1) Medical Event Involving Delivered Dose Less than the Prescribed Dose 2015-04-14T14:00:00 | |