ENS 43308
ENS Event | |
|---|---|
17:30 Apr 18, 2007 | |
| Title | Medical Event - Patient Received Dose Less Than Prescribed |
| Event Description | The following information is taken from a facsimile sent by Community Hospital Indianapolis:
A patient undergoing Yttrium-90 theraSphere treatment of the liver received an under dose. The original estimated intended dose was 301 Gray (Gy). The authorized user confirmed the setup during performance of the pre-administrative checklist. The under dose occurred due a mis-positioned stopcock that resulted in part of the intended source material being directed to a waste vial rather than the patient catheter. When the mis-directed (source) liquid was noted in the waste vial tubing, the authorized user re-checked the delivery system and corrected the stopcock orientation. Based on a delivered source activity of 3.28 GigaBecquerel (GBq), the estimated dose received by the patient is 130 Gy. The patient has been notified of the under dose. 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.
The following information was received as an update to this report via letter dated April 30, 2007 addressed to the Operations Center: After an investigation by the region III office, Community Hospitals, Indianapolis, Materials License Number 13-06009-01 is expanding the written follow-up to the verbal report of a medical event made 4/18/07, given Notification Number 43308 and the written report filed 4/18/07. Per 35.3045 (i) Licensee's Name: Community Hospitals of Indiana, Inc. (#13-06009-01) (ii) Name of Prescribing physician: [DELETED] (Authorized User) (iii) Brief Description of Event: Partial dose routed to waste vial because of incorrect stopcock orientation. The prescribed treatment site was the right liver lobe; the prescribed treatment site dose was 120 Gy. Because of the partial routing of the dose to the waste vial the dose delivered to the right liver lobe was 54.4 Gy. (iv) Why event occurred: Authorized user confirmed setup was correct when queried during the pre-administration checklist. However, stopcock was turned so that dose was directed to waste vial rather than into the patient delivery catheter. The interventional radiologist noted liquid in the waste vial tubing and directed the authorized user to stop; The authorized user re-checked the delivery system and corrected the stopcock orientation. The remainder of the dose was delivered to the patient. (v) Effect, if any, on the individual who received the administration: It is believed by the radiation oncologist and the interventional radiologist that there will be no effect on the patient. This treatment is one of several planned for this patient. Justification for this conclusion is that the original estimated tumor dose was 301 Gy based on the written directive of 120 Gy to the right lobe of the liver. Based on a delivered activity of 3.28 GBq, considering the tumor hypervascularity and volume, the estimated tumor dose is 130 Gy as a result of the 54.4 Gy delivered to the right liver lobe. This is within the dose range that the FDA has accepted for tumor dose in cases of liver metastases. (vi) Actions planned to prevent recurrence: A second individual (the interventional radiologist, radiologic technologist, nurse, or similarly trained individual) will be required to check the delivery setup portion in addition to the individual actually delivering the dose. This second check will be built in to the checklist. (vii) Certification that the licensee notified the individual (or the individual's responsible relative or guardian), and if not, why not: The interventional radiologist has notified the patient of the event. The referring physician was also notified of the event. This revised report will also be sent to the Operations Center. Notified R3DO (Bruce Burgess) and FSME (Greg Morell). |
| Where | |
|---|---|
| Community Hospital Indianapolis Indianapolis, Indiana (NRC Region 3) | |
| License number: | 13-06009-01 |
| Organization: | Community Hospital Indianapolis |
| Reporting | |
| 10 CFR 35.3045(a)(1) | |
| Time - Person (Reporting Time:+-3.17 h-0.132 days <br />-0.0189 weeks <br />-0.00434 months <br />) | |
| Opened: | Andrea Browne 14:20 Apr 18, 2007 |
| NRC Officer: | Gerry Waig |
| Last Updated: | May 15, 2007 |
| 43308 - NRC Website | |
Community Hospital Indianapolis with 10 CFR 35.3045(a)(1) | |
WEEKMONTHYEARENS 433082007-04-18T17:30:00018 April 2007 17:30:00
[Table view]10 CFR 35.3045(a)(1) Medical Event - Patient Received Dose Less than Prescribed 2007-04-18T17:30:00 | |