Browse wiki
Jump to navigation
Jump to search
The following information was provided by … The following information was provided by the PA Bureau of Radiation Protection (the Department) via email:</br>On December 12, 2025, a patient was receiving a Y-90 TheraSphere treatment. The prescribed dose was 131.08 mCi. The patient received a dose of 72.4 mCi. No effect on the patient occurred.</br>It is suspected that the cause was either the use of a third-party administration tubing set or a microcatheter defect, that caused a delay in administration leading to a clog in the line. The official cause is still under investigation.</br>The Department will perform a reactive inspection. More information will be provided as received.</br>PA event report ID number: PA250018</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.</br>* * * UPDATE ON 12/19/25 AT 1112 EST FROM JOHN CHIPPO TO KAREN COTTON * * *</br>The following additional information was provided by the PA Bureau of Radiation Protection (the Department) via email:</br>On December 12, 2025, a patient was receiving 2 doses of Y-90 TheraSphere to 2 treatment sites. The prescribed dose was 131.08 mCi. The administration set was connected using the Boston Scientific checklist and all pre-checks, flushes, and priming were satisfactory with proper flow confirmed for the delivery kit and microcatheter. Issues developed as the first (larger) dose delivery initiated including leakage at the C-line, increased pressure, and excessive saline diversion to the pressure release vial. The RADOS dosimeter reduced by 93 percent, suggesting successful administration, however, subsequent 4-point measurements indicated a dose delivery of only 60.8 percent. It was determined that a 44.7 percent deviation between prescribed and administered dose occurred. The second smaller dose displayed the same issues with leakage and excess saline diversion but was administered with greater than 90 percent delivery. The patient received a dose of 72.4 mCi. The referring physician and the patient were notified. There was no adverse impact to the patient.</br>It is suspected that the cause was the use of defective backup administration kits made by B. Braun, which were provided by Boston Scientific when the normal kits used at Thomas Jefferson University Hospital were unavailable due to backorder. The authorized user observed problems from the start of the administration including C-line clamp failure (requiring a hemostat to correct), increased pressure, and excess saline backflow to the pressure relief vial. An eventual obstruction occurred downstream after the dose vial and before the microcatheter, likely the clamp area between points 'D' and 'E' in the tubing. A high exposure rate was observed at this location (3.7 R/hr) while examining the waste materials supporting this location as having the obstruction. No other locations had exposure rates anywhere near this high.</br>A second dose was administered to the same patient to a different treatment site in the liver using a fresh backup administration kit and the problem with the failed C-clamp and increased saline backflow repeated. In this case the dose was successfully delivered, likely because it was a much smaller dose (less beads, less chance of clumping up and obstructing the line in an environment of abnormal flow dynamics).</br>The Department will perform a reactive inspection. More information will be provided as received.</br>Notified R1DO (Carfang) and NMSS Events Notification (Email)fang) and NMSS Events Notification (Email)
05:00:00, 12 December 2025 +
58,085 +
14:08:00, 15 December 2025 +
05:00:00, 12 December 2025 +
The following information was provided by … The following information was provided by the PA Bureau of Radiation Protection (the Department) via email:</br>On December 12, 2025, a patient was receiving a Y-90 TheraSphere treatment. The prescribed dose was 131.08 mCi. The patient received a dose of 72.4 mCi. No effect on the patient occurred.</br>It is suspected that the cause was either the use of a third-party administration tubing set or a microcatheter defect, that caused a delay in administration leading to a clog in the line. The official cause is still under investigation.</br>The Department will perform a reactive inspection. More information will be provided as received.</br>PA event report ID number: PA250018</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.</br>* * * UPDATE ON 12/19/25 AT 1112 EST FROM JOHN CHIPPO TO KAREN COTTON * * *</br>The following additional information was provided by the PA Bureau of Radiation Protection (the Department) via email:</br>On December 12, 2025, a patient was receiving 2 doses of Y-90 TheraSphere to 2 treatment sites. The prescribed dose was 131.08 mCi. The administration set was connected using the Boston Scientific checklist and all pre-checks, flushes, and priming were satisfactory with proper flow confirmed for the delivery kit and microcatheter. Issues developed as the first (larger) dose delivery initiated including leakage at the C-line, increased pressure, and excessive saline diversion to the pressure release vial. The RADOS dosimeter reduced by 93 percent, suggesting successful administration, however, subsequent 4-point measurements indicated a dose delivery of only 60.8 percent. It was determined that a 44.7 percent deviation between prescribed and administered dose occurred. The second smaller dose displayed the same issues with leakage and excess saline diversion but was administered with greater than 90 percent delivery. The patient received a dose of 72.4 mCi. The referring physician and the patient were notified. There was no adverse impact to the patient.</br>It is suspected that the cause was the use of defective backup administration kits made by B. Braun, which were provided by Boston Scientific when the normal kits used at Thomas Jefferson University Hospital were unavailable due to backorder. The authorized user observed problems from the start of the administration including C-line clamp failure (requiring a hemostat to correct), increased pressure, and excess saline backflow to the pressure relief vial. An eventual obstruction occurred downstream after the dose vial and before the microcatheter, likely the clamp area between points 'D' and 'E' in the tubing. A high exposure rate was observed at this location (3.7 R/hr) while examining the waste materials supporting this location as having the obstruction. No other locations had exposure rates anywhere near this high.</br>A second dose was administered to the same patient to a different treatment site in the liver using a fresh backup administration kit and the problem with the failed C-clamp and increased saline backflow repeated. In this case the dose was successfully delivered, likely because it was a much smaller dose (less beads, less chance of clumping up and obstructing the line in an environment of abnormal flow dynamics).</br>The Department will perform a reactive inspection. More information will be provided as received.</br>Notified R1DO (Carfang) and NMSS Events Notification (Email)fang) and NMSS Events Notification (Email)
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, 19 December 2025 +
PA-0130 +
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>.
12:20:06, 23 December 2025 +
14:08:00, 15 December 2025 +
3.38 d (81.13 hours, 0.483 weeks, 0.111 months) +
05:00:00, 12 December 2025 +
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.