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The following was received from the Common … The following was received from the Commonwealth of Massachusetts via e-mail:</br>On 2/12/10, licensee reported to this Agency (Commonwealth of Massachusetts) the 2/11/10 discovery of a medical event that occurred on 2/10/10. The situation (was) described as two treatment fraction underdoses, delivered on the same day to the same patient, that differed from the prescribed dose, per fraction, by more than 50%. Initial indication (is) that (the) event was caused by (an) equipment software bug. Two fractions of 0.4 Gy were delivered on the first day of treatment. The prescription was for two treatments of 4 Gy per fraction per day for two days and one final 4 Gy treatment on the third day. (The) prescribing physician and equipment manufacturer (were) notified. This is a preliminary report; investigation (is) ongoing; more information to follow.</br>The Agency considers this event OPEN and ONGOING.</br>* * * UPDATE FROM TONY CARPENITO TO JOE O'HARA VIA E-MAIL AT 1007 ON 2/17/10 * * *</br>(The) equipment manufacturer found the software issue to be 'reproducible' and therefore may be classified as a 'potential' (patient) safety issue.</br>(The) suspect portion of software will not be used again until (the) program (is) debugged and documented to be correct. (The) suspect portion of the software had not been used in the past by the licensee; no previous patients were affected.</br>The device has been identified as a Nucletron HDR V3, and the software program is named Oncentra. </br>Event docket #02-8893.</br>Notified R1DO(T. Jackson) and FSME EO(McIntosh)</br>* * * UPDATE FROM TONY CARPENITO TO HUFFMAN VIA E-MAIL AT 1448 ON 3/23/10 * * *</br>The equipment manufacturer published a customer information bulletin describing the problem. The licensee submitted a formal follow-up report to this Agency (Commonwealth of Massachusetts) on 2/25/10. The licensee wrote that since the underdose could be made up there will be no effect on the treatment outcome. There is no radiation morbidity. Patient underdose on 2/10/10 was 90%. The Agency considers this matter to be closed.</br>Notified R1DO(Caruso) and FSME EO(Kock).</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.
05:00:00, 10 February 2010 +
45,695 +
10:45:00, 12 February 2010 +
05:00:00, 10 February 2010 +
The following was received from the Common … The following was received from the Commonwealth of Massachusetts via e-mail:</br>On 2/12/10, licensee reported to this Agency (Commonwealth of Massachusetts) the 2/11/10 discovery of a medical event that occurred on 2/10/10. The situation (was) described as two treatment fraction underdoses, delivered on the same day to the same patient, that differed from the prescribed dose, per fraction, by more than 50%. Initial indication (is) that (the) event was caused by (an) equipment software bug. Two fractions of 0.4 Gy were delivered on the first day of treatment. The prescription was for two treatments of 4 Gy per fraction per day for two days and one final 4 Gy treatment on the third day. (The) prescribing physician and equipment manufacturer (were) notified. This is a preliminary report; investigation (is) ongoing; more information to follow.</br>The Agency considers this event OPEN and ONGOING.</br>* * * UPDATE FROM TONY CARPENITO TO JOE O'HARA VIA E-MAIL AT 1007 ON 2/17/10 * * *</br>(The) equipment manufacturer found the software issue to be 'reproducible' and therefore may be classified as a 'potential' (patient) safety issue.</br>(The) suspect portion of software will not be used again until (the) program (is) debugged and documented to be correct. (The) suspect portion of the software had not been used in the past by the licensee; no previous patients were affected.</br>The device has been identified as a Nucletron HDR V3, and the software program is named Oncentra. </br>Event docket #02-8893.</br>Notified R1DO(T. Jackson) and FSME EO(McIntosh)</br>* * * UPDATE FROM TONY CARPENITO TO HUFFMAN VIA E-MAIL AT 1448 ON 3/23/10 * * *</br>The equipment manufacturer published a customer information bulletin describing the problem. The licensee submitted a formal follow-up report to this Agency (Commonwealth of Massachusetts) on 2/25/10. The licensee wrote that since the underdose could be made up there will be no effect on the treatment outcome. There is no radiation morbidity. Patient underdose on 2/10/10 was 90%. The Agency considers this matter to be closed.</br>Notified R1DO(Caruso) and FSME EO(Kock).</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.
Has query"Has query" is a predefined property that represents meta information (in form of a <a rel="nofollow" class="external text" href="https://www.semantic-mediawiki.org/wiki/Subobject">subobject</a>) about individual queries and is provided by <a rel="nofollow" class="external text" href="https://www.semantic-mediawiki.org/wiki/Help:Special_properties">Semantic MediaWiki</a>.
00:00:00, 23 March 2010 +
60-0055 +
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>.
02:10:03, 2 March 2018 +
10:45:00, 12 February 2010 +
2.24 d (53.75 hours, 0.32 weeks, 0.0736 months) +
05:00:00, 10 February 2010 +
URL"URL" is a <a href="/Special:Types/URL" title="Special:Types/URL">type</a> and predefined property provided by <a rel="nofollow" class="external text" href="https://www.semantic-mediawiki.org/wiki/Help:Special_properties">Semantic MediaWiki</a> to represent URI/URL values.