ENS 46101
ENS Event | |
|---|---|
04:00 Jul 7, 2010 | |
| Title | Agreement State Report - Delivered Dose Differed from the Prescribed Dose by Greater than 50% |
| Event Description | The following was received via fax from the Pennsylvania Department of Environmental Protection:
On July 7, 2010 a patient was beginning the first of three vaginal treatment fractions with an Ir-192 HDR. It was discovered on July 14, 2010 that the end of the treatment tube was placed 3.5 cm short of its intended location. When the patient returned for the second treatment, she was imaged again, and staff noticed the treatment tube was in a different location from the previous treatment. Licensee estimates that, for the first fraction, the intended treatment volume received only about 10% of the intended dose for that fraction. Per 10CFR35.3045(a)(1)(iii), it is required for the licensee to report any event in which the fractionated dose delivered differs from the prescribed dose, for a single fraction, by 50% or more. It is believed the medical staff mis-identified the treatment location and the end of the treatment tube was placed 3.5cm short of its intended location. The licensee is considering making up this dose by adding a fourth treatment fraction. There is no anticipated adverse effect to the patient. There is a PaDEP/BRP reactive inspection scheduled to investigate this ME at U Penn. The patient and the referring physician were notified. A follow-up written report from the licensee is expected. PA Report # PA100015
The following was received via fax from the Pennsylvania Department of Environmental Protection: Due to further information received from the licensee, an amendment is being made to the original sent July 16, 2010, the CAUSE OF THE EVENT has been modified to reflect updated information. Event Description: On July 7, 2010 a patient was beginning the first of three vaginal treatment fractions with an Ir-192 HDR. It was discovered on July 14, 2010 that the end of the treatment tube was placed 3.5 cm short of its intended location. When the patient returned for the second treatment, she was imaged again, and staff noticed the treatment tube was in a different location from the previous treatment. Licensee estimates that, for the first fraction, the intended treatment volume received only about 10% of the intended dose for that fraction. Per 10CFR35.3045(a)(1)(iii), it is required for the licensee to report any event in which the fractionated dose delivered differs from the prescribed dose, for a single fraction, by 50% or more. CAUSE OF THE EVENT: The applicator was placed correctly by the medical staff as confirmed by MRI but moved 3.5 cm short of its intended location prior to treatment. The licensee is considering making up this dose by adding a fourth treatment fraction. There is no anticipated adverse effect to the patient. ACTION: There is a PaDEP/BRP reactive inspection scheduled to investigate this ME at U Penn. The patient and the referring physician were notified. A follow-up written report from the licensee is expected. 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 | |
|---|---|
| University Of Pennsylvania Philadelphia, Pennsylvania (NRC Region 1) | |
| License number: | Pa-0131 |
| Organization: | Pa Bureau Of Radiation Protection |
| Reporting | |
| Agreement State | |
| Time - Person (Reporting Time:+227.73 h9.489 days <br />1.356 weeks <br />0.312 months <br />) | |
| Opened: | David Allard 15:44 Jul 16, 2010 |
| NRC Officer: | John Knoke |
| Last Updated: | Jul 23, 2010 |
| 46101 - NRC Website
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University of Pennsylvania with Agreement State | |
WEEKMONTHYEARENS 570812024-04-17T04:00:00017 April 2024 04:00:00
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