ENS 44893
ENS Event | |
|---|---|
17:00 Mar 5, 2009 | |
| Title | Underdose to Patient Differs >20% of Intended Dose |
| Event Description | The following was provided by the state via e-mail:
Incident is a Medical Event per 15A NCAC 11.0364(a)(1)(A) where the EDE [effective dose equivalent] exceeds 5 Rem, and the total dose delivered differs from the prescribed dose by 20% or more. [This incident] occurred during the use of Y-90 TheraSpheres. It appears that the TheraSpheres became stuck in the source vial, and the entire dose could not be administered to the patient. This resulted in a 26.4% underdose to the patient. The licensee is investigating why the Medical Event occurred. The Agency [NCDENR] has requested that the licensee submit the source vial lot or batch number in the report to assist in the determination if it may have been a manufacturing error.
We were unable to obtain complete administration of the Y-90 TheraSphere dosage even after repeated flushes of thee dosage vial. The unadministered dosage appeared to remain in the dosage vial. Proper administration protocol was followed, and included four flushes of the vial. Two attempts were made to agitate and remove the remaining material by inverting the vial. The inversions were not completely successful at removing the remaining dosage. The decision was made to stop the administration after four flushes since the previous inversion and flush did not lower the dosimeter readings (a dosimeter is mounted on the delivery device which serves as an indicator of relative activity remaining in the dosage vial). The prescribed dosage was 44,7 mCi. It was estimated that [about] 32.9 mCi of the prescribed dosage was administered (73.6%). The intended dose to the right lobe of the liver was 120 Gy. The actual delivered dose to the right lobe was [about] 88.3 Gy. Although the other lobe of the liver (left) will be treated, there are no plans at this time to treat the right lobe again. MDS Nordion is conducting an investigation of this event. If deemed necessary upon completion of their investigation, supplemental procedures or recommendations will be provided to prevent further events of this type. Manufacturer representatives will be on-site on March 19, 2009 for further evaluation and follow-up. The TheraSphere dosage lot number was 9990019. A Medical Event may indicate potential problems in a medical facilities use of radioactive materials. It does not necessarily result in harm to the patient. |
| Where | |
|---|---|
| University Of North Carolina Hospitals Chapel Hill, North Carolina (NRC Region 1) | |
| License number: | 068-0565-1 |
| Organization: | Nc Div Of Radiation Protection |
| Reporting | |
| Agreement State | |
| Time - Person (Reporting Time:+17.78 h0.741 days <br />0.106 weeks <br />0.0244 months <br />) | |
| Opened: | James Albright 10:47 Mar 6, 2009 |
| NRC Officer: | Steve Sandin |
| Last Updated: | Mar 23, 2009 |
| 44893 - NRC Website | |
University Of North Carolina Hospitals with Agreement State | |
WEEKMONTHYEARENS 449792009-04-08T15:45:0008 April 2009 15:45:00
[Table view]Agreement State Agreement State Report - Misadministration Involving Y-90 Microspheres ENS 448932009-03-05T17:00:0005 March 2009 17:00:00 Agreement State Underdose to Patient Differs >20% of Intended Dose 2009-04-08T15:45:00 | |