ENS 43398
ENS Event | |
|---|---|
05:00 May 31, 2007 | |
| Title | Agreement State Report of a Medical Event Involving an Underdose |
| Event Description | The following information was received via email from the State of Wisconsin:
Event Report ID No.: WI070011 License No.: 079-1281-01 Licensee: Aurora St. Luke's Medical Center Event Location: Aurora St. Luke's Medical Center, Milwaukee, WI Event Type: Medical Event Notifications: RSO called DHFS 5/31/2007 Event description: On the morning of 5/31/2007 a Y-90 TheraSphere procedure was attempted. 1.05 GBq (28.3 mCi) was prescribed by the authorized user's written directive to deliver 123 Gy to the patient tumor. The activity in the dose vial was in agreement with this written directive. The TheraSphere Delivery Device (TDD) was appropriately set up by the radiopharmacist and the RSO, following the check list provided by the TheraSphere manufacturer, MDS Nordion. The interventional radiologist prepared the patient under fluoroscopy and positioned the catheter to fit his desired treatment site. This was completed at 9:30 a.m. At 9:40 the TDD was attached to the catheter. The TheraSphere injection was then started by the authorized user. The RSO was monitoring the radiation exposure in the room and did not see the normally-expected rise in exposure rate as the TheraSpheres enter the catheter and then the patient. After a few moments (after the injection of about half the balloon-inflator/syringe) the injection was stopped to evaluate what had happened. The authorized user and RSO then noticed that the blue stopcock was in the wrong position, directing the TheraSpheres into the waste vial and not into the patient. A radiation survey revealed that most of the radioactivity was now in the waste vial, very little (if any) in the patient, and some possibly remaining in the dose vial. It was decided to complete the normal four flushes of the dose vial into the patient, and to estimate the administered dose based on the activity in the waste vial. After the procedure the activity in the waste vial was measured in the dose calibrator in nuclear medicine. 25.9 mCi Y-90 was measured at 10:40 a.m. This constitutes approximately 94% of the activity that was originally in the dose vial (accounting for decay). The RSO estimates the dose delivered to the target volume in the patient liver is 6% of the intended dose, or 7 Gy. At 11:00 a.m. the RSO measured the exposure rate at the surface of the patient to be 0.00 Mr/hr with a GM survey meter and 0.0 Mr/hr with an ionization survey meter. Therefore, very little of the activity was injected into the patient. The waste vial is now being held for decay-in-storage. All personnel in the procedure, the TDD, and the room were surveyed and found to be free of contamination. The patient will be scheduled for re-treatment in the next few weeks. The licensee is evaluating the checklist provided by the manufacturer. DHFS will review the licensee's 15-day report and evaluate the licensee's proposed corrective actions. Media attention: None"
This event (EN43398) has been reviewed and determined to be a reportable medical event. 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 | |
|---|---|
| Aurora St. Luke'S Medical Center Milwaukee, Wisconsin (NRC Region 3) | |
| License number: | 079-1281-01 |
| Organization: | Wisconsin Radiation Protection |
| Reporting | |
| Agreement State | |
| Time - Person (Reporting Time:+29.25 h1.219 days <br />0.174 weeks <br />0.0401 months <br />) | |
| Opened: | Sean Matyas 10:15 Jun 1, 2007 |
| NRC Officer: | Steve Sandin |
| Last Updated: | Jun 7, 2007 |
| 43398 - NRC Website | |
Aurora St. Luke'S Medical Center with Agreement State | |
WEEKMONTHYEARENS 433982007-05-31T05:00:00031 May 2007 05:00:00
[Table view]Agreement State Agreement State Report of a Medical Event Involving an Underdose 2007-05-31T05:00:00 | |