ENS 41399
ENS Event | |
|---|---|
06:00 Jan 18, 2005 | |
| Title | Agreement State Report Involving Less than Planned Dose Fraction for Cervical Cancer |
| Event Description | The following is excerpted from a transmittal sent by the licensee and received on 2/3 by the State of KY concerning a medical event:
1. Licensee's name: Brown Cancer Center, University of Louisville Hospital 2. Prescribing physician's name: [Attending Physician] 3. A brief description of the event: On Tuesday, January 18, 2005 a patient was scheduled to undergo a vaginal cylinder HDR procedure using a 3.0 cm cylinder. The catheter was placed in position [under the supervision of the Attending Physician]. When the setup was complete, and upon leaving the room [the Resident Physician] noticed that the catheter was 'draped' around the patient's foot as it ran from the cylinder to the HDR machine. [The Resident Physician] 'undraped' the catheter from her foot, then all staff left the room. The treatment then ran for it's scheduled 5.5 minutes. After the treatment was completed, the Medical Physicist removed the catheter. He noticed that the catheter appeared to not be fully inserted into the cylinder as required and estimates that it may have been withdrawn from the desired location by approximately 15 cm. He promptly informed [the Attending and Resident Physicians] and together informed [the] Chairman of Radiation Oncology. 4. Effect on the individual: This treatment was the second of three treatments prescribed. The patient is being monitored and no adverse effects to the patient are expected nor did any occur. 5. Why the event occurred: The event occurred due to the lack of a positive mechanical 'lock' of the HDR catheter to metal guide insert tube. The system uses a moveable nylon collar surrounding the catheter, which is slid into position once the catheter is placed into the metal guide insert tube. A nut is then screwed over the nylon collar forming a 'compression' fitting much like that used for compression fittings on copper-tubing. The event may have occurred when [the Resident Physician] 'undraped' the catheter which was 'draped' around the patient's foot. The nylon collar-nut compression fitting may have allowed the catheter to be pulled partially out of the metal guide tube. 6. What improvements are needed to prevent recurrence The manufacturer also offers a different type of collar-nut compression fitting utilizing a stainless steel collar that is glued onto the catheter at the appropriate distance. This constitutes a 'positive' mechanically locked position for the catheter. This alternate system is being readied for use henceforth. 7. Action taken to prevent recurrence: The catheter is now length/position marked and is checked by both the physician and the physicist prior to leaving and upon re-entering the HDR suite. A soon as the parts are assembled for the stainless steel type of collar, the HDR catheters will be switched over to the new equipment. This will provide a 'positive' lock on catheter length into the metal guide tube assembly. 8. If licensee informed the individual or individual's responsible relative or guardian, and if not, why: The patient and referring physician were informed of the situation by [the Attending Physician]. 9. Information provided to the individual or individual's responsible relative or guardian: The patient was informed that she may have received a dose lower than that prescribed to the area of intended treatment. She was informed that the treatment would not be repeated (this was the second of three treatments planned) as it was not absolutely clear if an under dose occurred. She was told that she would be carefully monitored for progress. A followup transmittal from the licensee received on 2/9 by the state of KY provided estimated dose data: As the report described, during the treatment the source for the HDR may have been withdrawn from the desired treatment site by 15 cm. The dose desired for the 5.5 minute treatment was seven hundred and fifty (750) cGy to the site of interest. With the source offset by 15 cm, the delivered dose would have been four (4) cGy. Assuming that the source was in fact approximately 2 cm exterior to the vagina, the dose at the labia would have been one hundred (100) cGy. |
| Where | |
|---|---|
| University Of Louisville Louisville, Kentucky (NRC Region 1) | |
| License number: | 202-029-22 |
| Organization: | Kentucky Dept Of Radiation Control |
| Reporting | |
| Agreement State | |
| Time - Person (Reporting Time:+561.88 h23.412 days <br />3.345 weeks <br />0.77 months <br />) | |
| Opened: | Rick Horky 15:53 Feb 10, 2005 |
| NRC Officer: | Steve Sandin |
| Last Updated: | Feb 10, 2005 |
| 41399 - NRC Website | |
University Of Louisville with Agreement State | |
WEEKMONTHYEARENS 520502016-05-18T05:00:00018 May 2016 05:00:00
[Table view]Agreement State Agreement State Report - Patient Overdose of Iodine-125 During Medical Treatment ENS 413992005-01-18T06:00:00018 January 2005 06:00:00 Agreement State Agreement State Report Involving Less than Planned Dose Fraction for Cervical Cancer 2016-05-18T05:00:00 | |