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| Start date | Reporting criterion | Title | Event description | System | LER | |
|---|---|---|---|---|---|---|
| ENS 44979 | 8 April 2009 15:45:00 | Agreement State | Agreement State Report - Misadministration Involving Y-90 Microspheres | The following was received via facsimile: N.C. Radiation Protection Section was notified of a misadministration involving Y-90 microspheres. The licensee reports that the administered dosage was 24 percent less than the prescribed dosage. Licensee reports no equipment malfunction and no leakage of radioactive material from the delivery device. Licensee has notified patient and there are no plans to perform a second administration. Licensee is contacting vendor to assist in investigation. N.C. Radiation Protection has not received any media attention as of this report. No press release has been issued. The North Carolina Event Report ID Number for this event is NC-09-22. 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. | ||
| ENS 44893 | 5 March 2009 17:00:00 | Agreement State | Underdose to Patient Differs >20% of Intended Dose | 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. Notified R1DO (J. Dwyer) and FSME EO (L. Camper) 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. |