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| Start date | Reporting criterion | Title | Event description | System | LER | |
|---|---|---|---|---|---|---|
| ENS 53512 | 17 July 2018 05:00:00 | Agreement State | Agreement State Report - Total Dose Delivered Differed from Prescribed Dose by Greater than 20 Percent | The following information was received from the state of Wisconsin via email: On July 17, 2018, the licensee identified a medical event where the total dose delivered differed from the prescribed dose by 20 percent or more. The licensee implanted 83 seeds containing Pd-103 for prostate brachytherapy. The prescribed dose to the prostate was 125 Gy; the dose delivered was 96.25 Gy. The dose received by the prostate (D90) was 77 percent of the intended dose. The patient has been notified. The implant occurred on June 8, 2018, and post-implant dosimetry was completed on July 17, 2018. The department will perform a site investigation to determine the root cause of this medical event. Event Report ID No.: WI180011 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 41620 | 19 April 2005 06:00:00 | Agreement State | Equipment Failed to Function as Designed | The following information was provided by the State via facsimile: On Wednesday, April 19, 2005 while loading a Pd-103 seed into the Mick applicator, the applicator jammed. When the operating room technician attempted to get the seed loose, the seed broke. This spread a small amount of radioactive contamination onto the table, which was cleaned up by the RSO and dosimetrist. The applicator was found to be contaminated. It was put in a plastic bag, placed behind lead shielding and locked in the Nuclear Medicine hot lab. The activity of the Pd-103 seed was 1.578 mCi (millicuries). According to the licensee, there was no overexposure, contamination, or intake of radiation by anyone present in the operating room. The patient was treated, as per the prescription after borrowing a Mick applicator from another hospital. The licensee notified DHFS on April 20, 2005. The licensee also contacted their consultant and their MIC applicator distributor regarding the event. A replacement applicator is being sent and the contaminated applicator will be allowed to decay before servicing. The licensee has developed, an action plan for this event based on possible causes: 1. Look into the possibility of having the MIC applicator on a preventative maintenance schedule. 2. Change the sterilization procedure such that central supply does the cleaning of the applicator, not the OR technician. 3. Set up a 'core' group of OR technicians who are involved in their procedure, and document their education. A voluntary MedWatch form was sent in to the FDA. Wisconsin Radiation Protection Section plans on investigating this event. State Event Report ID # 24. | ||
| ENS 41008 | 31 August 2004 19:00:00 | Agreement State | Wisconsin Agreement State Report: Source Failed to Retract | On the evening of August 31, 2004 during a mammosite treatment utilizing a Varian HDR unit, the source failed to retract upon completion of the treatment time. The licensee's RSO/AMP had to enter the treatment room and retract the source manually. The licensee subsequently contacted Varian for assistance. A service representative from Varian arrived at Aurora Baycare Medical Center on Wednesday, Sept. 1, 2004. The Varian service representative found nothing wrong with the HDR unit. However, approximately 2 cm of the connecting catheter had 'buckled' (appeared melted and twisted), possibly restricting source movement. The licensee has contacted the catheter manufacturer for assistance in analyzing the catheter to determine what may have caused it to buckle. Preliminary dose indications by the licensee indicate that the patient received an additional amount of dose to the skin while the source was being retracted. The licensee reported that the most probable estimate of the additional skin dose is 1.0 Gy. |