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The following information was received fro … The following information was received from the State of Georgia via email:</br>Emory University had new software installed for their HDR on 2/2/2016. During the time span of 3/2016 through 6/2017 (five) 5 patients received doses that were greater than 20% (percent) and greater than 50 rem to the targeted area. The misadministration was due to a software defect with Elekta's Oncentra Brachy Software version 4.5.2. using the ring applicator. The licensee was only aware of the defect on Aug 22, 2017 when Elekta notified all of their customers of the defect. Emory unofficially notified the State of Georgia on Aug 24, 2017 of a possibility that several of their patients may have been involved in a medical event. The medical event was confirmed on Sept 19, 2017 that (five) 5 patients were involved in a medical event.</br>Cause and Corrective Actions: The events were due to a software issue utilizing the Oncentra Brachy Software version 4.5.2. A misadministration occurred due to an inconsistent step size when treating the ring source path. A source step size of 2.5 mm was planned. What was reported in the case explorer was a 5 mm step size. </br> "Device/Associated Equipment: Oncentra Brachy Software version 4.5.2. in a Elekta Nucleotron MicroSelection v3 HDR using a ring applicator.</br>The targeted area that received the greater than 50 rem was the tissue of the upper vaginal wall. </br>The defect in the equipment is identified and described in EN #52922.</br>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.necessarily result in harm to the patient. +
04:00:00, 24 August 2017 +
52,979 +
10:38:00, 19 September 2017 +
04:00:00, 24 August 2017 +
The following information was received fro … The following information was received from the State of Georgia via email:</br>Emory University had new software installed for their HDR on 2/2/2016. During the time span of 3/2016 through 6/2017 (five) 5 patients received doses that were greater than 20% (percent) and greater than 50 rem to the targeted area. The misadministration was due to a software defect with Elekta's Oncentra Brachy Software version 4.5.2. using the ring applicator. The licensee was only aware of the defect on Aug 22, 2017 when Elekta notified all of their customers of the defect. Emory unofficially notified the State of Georgia on Aug 24, 2017 of a possibility that several of their patients may have been involved in a medical event. The medical event was confirmed on Sept 19, 2017 that (five) 5 patients were involved in a medical event.</br>Cause and Corrective Actions: The events were due to a software issue utilizing the Oncentra Brachy Software version 4.5.2. A misadministration occurred due to an inconsistent step size when treating the ring source path. A source step size of 2.5 mm was planned. What was reported in the case explorer was a 5 mm step size. </br> "Device/Associated Equipment: Oncentra Brachy Software version 4.5.2. in a Elekta Nucleotron MicroSelection v3 HDR using a ring applicator.</br>The targeted area that received the greater than 50 rem was the tissue of the upper vaginal wall. </br>The defect in the equipment is identified and described in EN #52922.</br>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.necessarily result in harm to the patient. +
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00:00:00, 20 September 2017 +
GA 153-1 +
Modification date"Modification date" is a predefined property that corresponds to the date of the last modification of a subject and is provided by <a rel="nofollow" class="external text" href="https://www.semantic-mediawiki.org/wiki/Help:Special_properties">Semantic MediaWiki</a>.
22:50:44, 24 November 2018 +
10:38:00, 19 September 2017 +
26.276 d (630.63 hours, 3.754 weeks, 0.864 months) +
04:00:00, 24 August 2017 +
Agreement State Report - Dose Delivered 20% Greater than Prescribed and Greater than 50 Rem to the Targeted Area +
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