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| Start date | Reporting criterion | Title | Event description | System | LER | |
|---|---|---|---|---|---|---|
| ENS 47558 | 29 December 2011 14:00:00 | 10 CFR 20.1906(d)(1) | Radiopharmaceutical Package Received with External Contamination | The Radiation Safety Officer of St. Vincent Hospital reported that the facility received a radiopharmaceutical shipment of I-131 with excess surface contamination on the outside of the shipping container. When the surface of the shipping container was initially swipe tested, the contamination was measured at 734 dpm per 100 sq centimeters. A follow-up swipe survey pinpointed the contamination to just one side of the shipping container and was found to be 581 dpm per 100 sq centimeters. Additional isotopic analysis determined that the radioactive contaminant was I-131. Integrity of the package was not compromised. The inside of the shipping container was tested and found to be clean. The two I-131 vials in the container were also verified to be intact and clean. The hospital called the radiopharmaceutical supplier, Cardinal Health Systems of Indianapolis, to notify them of the contamination found on the package. The shipping container has been isolated in a controlled area at St. Vincent Hospital. | ||
| 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 43702 | 8 October 2007 04:00:00 | 10 CFR 20.2202(a)(1) | Potential Personnel Overexposure | A representative of Landauer (the optically stimulated dosimeter provider) reported to the hospital that a person on the hospital staff received a 113,165 millirem deep dose whole body reading for the reporting period of 8/1/07 - 8/31/07. The shallow dose reading was 107,506 millirem. The Radiation Safety Officer (RSO) contacted the individual with the high dose reading. The individual said that he had no ill health effects so he believed the reading was not correct. The individual said that he normally wears his dosimeter attached to a lanyard that he wears around his neck. He did remember one day when a therapist brought him his dosimeter from a linear accelerator room. The individual did not recall leaving his dosimeter in the room. The RSO talked to a representative of Landauer about distinguishing between a potential dose from an accelerator and other doses the individual may have received from performing his duties but this could not be definitively done. | ||
| 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. | ||
| ENS 42518 | 20 April 2006 18:10:00 | 10 CFR 20.1906(d)(1) | Technetium 99M Surface Contamination Found on Package Exterior | St. Vincent Hospital received a package with surface contamination levels excess of Department Of Transportation 49 CFR 173.443 required levels. The package was an expected shipment of Iodine 131 for hospital use. The Hospital identified the contaminant via exterior swipe surveys as Technetium 99m at levels in excess of 5200 decays per minute per 100 centimeters squared. The integrity of the package was not compromised. No contamination was found on the interior of the package. The hospital called the shipper, Cardinal Health Systems, to notify them of the contamination found and has isolated the package in a controlled area.
The licensee is retracting this event based on the fact that the reported surface contamination levels are not above the DOT limits referenced above. Notified NMSS (Morell), R3DO (Peterson). | ||
| ENS 41133 | 11 October 2004 06:00:00 | 10 CFR 35.3045(a)(1) | Medical Event Involving Fractionated Dose Delivery Less than Prescribed | On 10/11/04 a 49 year old female patient received the first of two treatments for endometrial cancer. A total dose of 700 centiGray was prescribed to be delivered in two (2) 350 cGy fractions using a 1500 mm length catheter containing a 7.035 curies Ir-192 source (duration 189 seconds). Due to an error on the part of the Health Physicist, the 995 mm length catheter was used. This resulted in a calculated dose of less than 1 cGy to the thigh at a distance of 505 mm from the intended site. There are no expected adverse consequences. Both the patient and prescribing physician were informed. A new treatment plan has been developed and the patient rescheduled. Corrective actions are to be determined. The licensee informed Region 3 (Mike Lafranzo).
The following text is an updated corrected version of the above initial report which was submitted by the licensee after consulting with Region 3. On 10/11/04 a 49 year old female patient received what was to be the first of two High Dose Rate (HDR) treatments for endometrial cancer using a remote afterloading unit. The physician planned two fractions of 350 cGy for a total of 700 cGy at 0.5 cm from the GYN cylinder (2.0cm) wall using a 7 Ci Ir-192 source. The GYN cylinder is connected to the HDR unit using a 1500 mm transfer tube. A treatment of 189 seconds with an active length of 5 cm was to be treated with an indexer position of 1500 mm, Due to an error on the part of the medical physicist, an indexer length of 995 was programmed into the treatment unit. This resulted in the source not entering the patient. The source remained positioned in the transfer tube for the treatment duration at an estimated distance of 35-50 cm from the patient's skin. This resulted in a calculated dose between 1.4 - 4.3 R to the patient's skin. There are no expected adverse consequences. Notified Reg 3 RDO (Julio Lara) and NMSS EO (Sandra Wastler) | ||
| ENS 40643 | 5 April 2004 17:00:00 | 10 CFR 35.3045(a)(1) | Medical Event Involving Fractionated Dose Delivery Higher than Prescribed | A patient was prescribed five (5) fractional treatments of 500 centigray each to the surface using a 6.7 curie Ir-192 brachytherapy source. On 3/15, 3/22 and 3/29/04 the patient received 500 centigray/fraction at a depth of 5 mm. This resulted in a delivered dose of 818 centigray/fraction at the surface. The error was discovered prior to delivering the fourth (4th) fraction and is attributed to a miscalculation. The prescribing physician has been informed and concluded that there would be no adverse effects to the patient. The licensee is implementing additional reviews to preclude this type of event from reoccurring. |