The following report was received by the
Pennsylvania Bureau of Radiation Protection, Department of Environmental Protection (the Department) via email:
On June 6, 2025, the licensee informed the Department of a medical event. It is reportable as per 10 CFR 35.3045. On that day, the licensee was performing a Lu-177 dotatate procedure when it was noticed about halfway into the procedure that the pump infusion setup had a slow, obscured, and contained leak onto underlying absorbent paper. The procedure was then stopped. The prescribed dose was 200mCi and it is estimated at this time that approximately 70-90 mCi were administered. Both the referring physician and the patient were notified the same day. No overexposures were recorded. No harm is expected to the patient.
The Department will perform a reactive inspection. More information will be provided as received.
PA NMED Event Number: PA250010
- * * UPDATE ON 6/12/2025 AT 0934 EDT FROM JOHN CHIPPO TO ERNEST WEST * * *
The following report was received by the Pennsylvania Bureau of Radiation Protection via email:
On June 6, 2025, the licensee was performing the second (of four) Lu-177 dotatate (Lutathera) treatments. The patient was prescribed 200 mCi of Lu-177 dotatate. A slow, obscured leak in the side port of the 3-way stopcock was discovered approximately halfway through the 30-minute administration despite the side-port being properly capped. The remaining dosage (11.4 ml of 25 ml) was slowly pushed by hand after an adjustment was made to the stopcock to stop the leak and the infusion was completed. Subsequent radiological measurements by radiation safety of the absorbent containing the leaked material and of the patient were immediately presumptive for a significant loss of material, which was confirmed by additional measurements and calculations. A medical event was declared upon finding the patient received less than 80 percent of the intended dose. It is estimated that approximately 88.4 mCi were administered. All leaked material was contained to the underlying, leakproof absorbent and the articles situated upon it; no other areas of contamination were found. Both the referring physician and the patient were notified the same day. No overexposures were recorded. No harm is expected to the patient.
Notified R1DO (Warnek), and NMSS Events Notification (email)
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.