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The following information was received fro … The following information was received from the Commonwealth of Massachusetts via email:</br>On November 2, 2021, 3:00 PM (EDT), licensee reported medical event under license 60-0160 for Sirtex Wilmington LLC SIR-Spheres Y-90 microspheres (SS&D MA-1229-D-101-S) emerging technology for total administered activity that differed from prescribed treatment activity as documented in the written directive by 20 percent or more. A portion of a Y-90 5 mCi microsphere therapy treatment delivered to patient liver on November 2, 2021 remained in the delivery system causing delivery of approximately 3.67 mCi Y-90 of the prescribed 5 mCi. The error was discovered immediately after treatment. Administered dose to treatment area differed from prescribed dose by approximately 27 percent. Licensee stated the cause, including possible equipment malfunction, has not yet been determined. Prescribing physician, referring physician and patient have been notified. Licensee stated no negative health effects to patient due to situation. No additional Y-90 therapy treatment would be required due to this situation. Licensee stated all Y-90 was accounted for. Licensee stated 5 mCi prescription was unusually small compared to previous procedures (range 9-to-39 mCi with 15 mCi being the most prescribed dose). Licensee to submit written report within 15 days of discovery date. This is a next day reportable medical event per regulation.</br>Investigation ongoing. Agency considers this event docket to still be OPEN.</br>Report by Anthony Carpenito, 11/3/2021. OPEN.
Report by Anthony Carpenito, 11/3/2021. +
17:25:00, 2 November 2021 +
55,557 +
12:08:00, 3 November 2021 +
17:25:00, 2 November 2021 +
The following information was received fro … The following information was received from the Commonwealth of Massachusetts via email:</br>On November 2, 2021, 3:00 PM (EDT), licensee reported medical event under license 60-0160 for Sirtex Wilmington LLC SIR-Spheres Y-90 microspheres (SS&D MA-1229-D-101-S) emerging technology for total administered activity that differed from prescribed treatment activity as documented in the written directive by 20 percent or more. A portion of a Y-90 5 mCi microsphere therapy treatment delivered to patient liver on November 2, 2021 remained in the delivery system causing delivery of approximately 3.67 mCi Y-90 of the prescribed 5 mCi. The error was discovered immediately after treatment. Administered dose to treatment area differed from prescribed dose by approximately 27 percent. Licensee stated the cause, including possible equipment malfunction, has not yet been determined. Prescribing physician, referring physician and patient have been notified. Licensee stated no negative health effects to patient due to situation. No additional Y-90 therapy treatment would be required due to this situation. Licensee stated all Y-90 was accounted for. Licensee stated 5 mCi prescription was unusually small compared to previous procedures (range 9-to-39 mCi with 15 mCi being the most prescribed dose). Licensee to submit written report within 15 days of discovery date. This is a next day reportable medical event per regulation.</br>Investigation ongoing. Agency considers this event docket to still be OPEN.</br>Report by Anthony Carpenito, 11/3/2021. OPEN.
Report by Anthony Carpenito, 11/3/2021. +
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, 3 November 2021 +
60-0160 +
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>.
12:30:18, 12 November 2021 +
12:08:00, 3 November 2021 +
0.78 d (18.72 hours, 0.111 weeks, 0.0256 months) +
17:25:00, 2 November 2021 +
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.