On January 15, 2018 a medical event occurred at the licensed facility in which a patient received a prescribed dose less than 80 percent of the target dose to the liver. The dose was delivered via
Y-90 microspheres.
The State will investigate this medical event.
- * * UPDATE FROM DARYL LEON TO HOWIE CROUCH VIA EMAIL AT 1616 EST ON 1/19/18 * * *
On January 15, 2018, a patient was prescribed a dose of 130 Gy (2.789 GBq) for the left lobe of the liver involving two dose vials of Y-90 MDS Nordion TheraSphere microspheres. The first dose vial was administered without issue. The second dose vial was then primed and prepped as normal, however, a train of bubbles was noted in the line between the dose vial and the patient prior to administration. Due to the proximity of gastric artery relative to point of administration and the possibility that the bubbles could cause the flow to reflux into this artery (which could permanently damage the stomach), the AU [Authorized User] determined the best course of action was not to administer the second dose vial. The therapy procedure was then halted and rescheduled to complete on Thursday, January 18th.
The administered dose was 84.9 Gy (1.760 GBq) to the left lobe of the liver. The dose was therefore 65% of the prescribed dose, a 35% difference. The difference between the prescribed and administered dose to the liver is 45.1 Gy (4510 rem). Therefore, the dose administered exceeds +/- 20% of prescribed dose and differs from the prescribed dose by more than 50 rem to an organ (liver).
The referring physician has been notified as well as the patient.
This event was reported to the Oregon Agreement State program on January 16, 2018.
The licensee has removed all Y-90 therapy tubing sets from the same lot number for return and analysis by the vendor. Tubing sets from a different lot number were provided to interventional radiology for future cases.
Notified R4DO (Proulx) and NMSS Events Resource (email).
State Event Report ID No.: OR-18-0001
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.