Semantic search
| Start date | Reporting criterion | Title | Event description | System | LER | |
|---|---|---|---|---|---|---|
| ENS 46949 | 15 May 2011 05:00:00 | Agreement State | Agreement State Report - Medical Events Involving Use of Savi Brachytherapy Applicators | The following information was provided by the State via facsimile: On June 10, 2011, the licensee's Radiation Safety Officer reported the identification of two medical events involving a HDR (High Dose Rate) Partial Breast Treatment using SAVI applicators. For both patients, treatment was delivered twice a day for five consecutive days in May 2011. It was determined later that the distance as determine by use of a Varian VariSource check ruler was incorrect. The check wire was blocked approximately 4.5 cm from the end of the lumen. The preliminary results from re-planning indicates that in both cases the most distal half of the applicator was under dosed at least 20 percent and the proximal half received approximately 200 percent more dose than what was prescribed. The patients will be notified by the referring physician. The licensee has suspended SAVI treatments until the root cause can be identified. Further updates will be made through NMED. The State of Wisconsin Department of Health Services will conduct a special inspection at the licensee's location. Wisconsin Report No: WI 110006 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. | ||
| ENS 46529 | 10 January 2011 06:00:00 | Agreement State | Agreement State Report - Prostate Brachytherapy Misdosing | The following information was received from the State of Wisconsin via fax: On January 10, 2011, the licensee's Radiation Safety Officer reported the identification of ten medical events involving permanent implants of I-125 for prostate brachytherapy where the total dose delivered differs from the prescribed dose by 20% or more. During a recent routine inspection, Department of Health Services inspectors determined that the licensee was not reviewing prostate brachytherapy cases against medical event criteria. The licensee is identifying as a medical event any case where D90<135 Gy or D90>195 Gy for patients who receive seed implants only, and D90<100 Gy or D90>145 Gy for patients who receive seed implants in conjunction with external beam therapy (combined therapy). The licensee performed a comprehensive review of all 82 prostate implants performed since August 2003. The licensee's ten medical events include six overdoses to the prostate and four underdoses to the prostate. No medical events were identified involving doses to other organs or tissue above 0.50 Sv and 50% more than the expected dose. The licensee has notified the referring physicians and will not be notifying the affected patients per DHS 157.72(1). Overdoses (medical event criteria used - D90>195 Gy): 12/23/2003: 204.95 Gy; 10/27/2004: 160.49 Gy (combined therapy, medical event criteria used - D90>145 Gy); 1/20/2006: 211.23 Gy; 6/14/2006: 207.03 Gy; 9/5/2007: 205.7 Gy; and 10/17/2007: 210.47 Gy. Underdoses (medical event criteria used - D90<135 Gy): 9/26/2003: 123.03 Gy; 10/31/2003: 116.78 Gy; 1/14/2004: 126.73 Gy; and 3/31/2009: 123.74 Gy. DHS will send a special inspection team to determine the root cause(s) of these medical events on February 2, 2011.
This is an update to Event Notification 46529. On January 31, 2011, the licensee retracted one medical event for a prostate brachytherapy patient treated on 3/31/2009 based on refined post-implant dosimetry. Further updates will be made through NMED. DHS will send a special inspection team on February 3 2011. " WI Event Report ID No.: WI 110001 Update Notified FSME(Angela McIntire) and R3DO (Richard Skokowski) 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. | ||
| ENS 43288 | 4 April 2007 05:00:00 | Agreement State | Improper Applicator Length Leads to Wrong Dose | St. Vincent Hospital, (Green Bay, Wisconsin) notified (the state of Wisconsin) of a medical event by telephone, on April 5, 2007. The medical event occurred on April 4, 2007 and involved an HDR unit. Initial information indicated an incorrect length of catheter was used during the treatment. A (state) inspector was dispatched to the facility on April 6, 2007. On April 4, 2007, a patient was scheduled for a single-fraction interstitial treatment using a Varian Vari-Source HDR unit containing 6.24 Curies of Iridium-192. The patient was to receive 900 centigray to the vagina. An incorrect applicator length (100 cm) was input into the treatment plan. The actual applicator length was 120 centimeters. The source is believed not to have entered the patient's body during treatment. The authorized user and the patient were notified, and the patient will return for retreatment on April 12. The licensee is performing their own investigation into the event, including a reenactment of the 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. |