ENS 41135
ENS Event | |
|---|---|
05:00 Jun 3, 2004 | |
| Title | Agreement State Report - Multiple Patient Overexposure |
| Event Description | A verbal report was received on July 20, 2004, which reported patient doses in excess of 50 Rem to the wrong physical area on treatments involving a Nucletron HDR Microselectron brachytherapy device, Model 080.000, Serial No. 9072. Four patients received wrong doses due to a 7.5 centimeter error in source location from the intended treatment site/plan. Details were vague due to discussion over the phone. A written report would follow.
The written report date August 2, 2004, was received by this agency on August 6, 2004. The report failed to give details needed by this agency. An Agency investigator was assigned to investigate this incident on August 6, 2004. The investigation conducted on August 18, 2004, determined that an error in catheter length was entered by two different registered therapists as 920 millimeters versus the default and actual length of the catheter of 955 millimeters. The 75 millimeter or 7.5 centimeter error resulted in two sources: a 12.3 curie (02/16/2004) Ir-192 source, Serial No. D35AO131 and a new Ir-192 source installed on 07/08/2004, Serial No. D35A0605, 10.5 curies being positioned outside of each patients body. The error was discovered after one of the four patients developed skin erythema. The patients were to receive boost treatments of 500 centiGray per fraction from the HDR unit to the prescribed location with the total number of fractions varying from 3 to 7 in the physician's written directive. The patients were all being treated for inter uterine cancer. The patients received fractional treatments with the error which varied from 1-5 fractions. Make-up treatments were required on three of the patients to achieve the correct dosage to the treatment site. Some patients received both correct and incorrect treatments from the same therapists. The error was discovered on July 8, 2004, when one patient complained of tenderness in one leg. The physician determined that the patient had erythema on her leg, several centimeters from the planned treatment site. The physician's investigation determined the error in catheter length on July 14, 2004, and ordered make-up treatment for his patient on July 15, 2004. A total of four female patients, three radiation oncologists, and three radiation therapists were involved in the treatments and required corrective treatments to three of the four patients. The hospital was reluctant to release dose data on the patients due to concerns of HIPAA privacy standards. After explanation of allowable disclosure to this agency, the Licensee provided the data on October 4, 2004. Patient #1 received a non-target tissue dose of 800 rad superficial and 250 rad deep over a three week period. She suffered skin erythema which was treated over a few weeks with rest and a topical ointment. After the erythema was resolved she resumed normal follow-up treatment for her initial disease. Patient #2 received a non-target tissue dose of 400 rad superficial and 150 rad deep over a one week period and exhibited no abnormal reactions. She immediately resumed normal follow-up treatment for her initial disease. Patient #3 received a non-target tissue dose of 1100 rad superficial and 300 rad deep over a three week period. She exhibited no abnormal reactions and resumed normal follow-up treatment for her initial disease. Patient #4 received a non-target tissue dose of 1800 rad superficial and 350 rad deep over a seven week period. She suffered skin erythema and was treated with rest and topical ointment. After the erythema was resolved, she resumed normal follow-up treatment for her initial disease. This is an abnormal occurrence. Texas Incident # I-8145.
The correct catheter length is 995 mm vs. the entered length of 920 mm. A difference of 75 mm or 7.5 cm. Notified R4 DO (Whitten) and NMSS EO (Essig). |
| Where | |
|---|---|
| Vhs San Antonio Partners, Lp San Antonio, Texas (NRC Region 4) | |
| License number: | L00455-000 |
| Organization: | Texas Department Of Health |
| Reporting | |
| Agreement State | |
| Time - Person (Reporting Time:+3323.62 h138.484 days <br />19.783 weeks <br />4.553 months <br />) | |
| Opened: | James Ogden 16:37 Oct 19, 2004 |
| NRC Officer: | Jeff Rotton |
| Last Updated: | Oct 20, 2004 |
| 41135 - NRC Website | |
Vhs San Antonio Partners, Lp with Agreement State | |
WEEKMONTHYEARENS 411352004-06-03T05:00:0003 June 2004 05:00:00
[Table view]Agreement State Agreement State Report - Multiple Patient Overexposure 2004-06-03T05:00:00 | |