ENS 55933
ENS Event | |
|---|---|
07:00 Jun 7, 2022 | |
| Title | Underdose to Treatment Site |
| Event Description | The following information was received from the Washington State Department of Health via email:
On 06/08/2022, Inland Northwest (INW) Multicare's radiation safety officer (RSO) reported a medical event had occurred. A Y-90 therasphere procedure was done on the previous day (06/07/2022), the procedure went according to plan, however after the procedure was completed the after injection surveys and quality assurance was done, it revealed that a portion of the microspheres did not come out of the tubing as designed. After calculation it was determined that the patient only received 26 percent of the target dose. The licensee immediately notified the manufacturer to see what happened. The manufacturer told them this is a known issue and has happened before. INW is writing up a full report and will submit it when completed. WA incident No.: WA-19-004 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.
The following is a summary of information received via E-mail: There has been no indication of non-target embolization delivered to the patient. Crucially, no patient harm has resulted from this medical event. The patient has been contacted and notified by the Authorized User as to the reduced dosage administration during the procedure and is doing well with no indication of post procedure complications. The conclusion that was arrived at, after the span of this investigation, is that a definitive root cause cannot be drawn as to why this event occurred. Given all of the information that has been gathered, the source of this medical event can be attributed to microspheres settling out and/or clogging in the delivery system. Whether this can be attributed to the technique used by the performing physician or an equipment failure I cannot definitively say. What is known is over 70 percent of the activity remained in the delivery system and more specifically the tubing. Had the activity that remained in the delivery system been delivered to the patient, there would not have been a medical event occurrence. The known documented and published cases of the microspheres settling out and/or clogging in the delivery system are attributed more commonly to equipment failure as opposed to administration techniques. Given this data it is reasonable to conclude that equipment failure is the most likely cause of this medical event. What is also know through the investigation, is that all proper procedures were followed throughout the entire duration of this procedure. Because of that, there are no corrective actions that can be identified to prevent recurrence. This concludes the investigation. Notified the R4DO (Azua) and the NMSS Events Notification E-mail group. |
| Where | |
|---|---|
| Inw Multicare Health Spokane, Washington (NRC Region 4) | |
| License number: | WN-M005-1 |
| Organization: | Wa Office Of Radiation Protection |
| Reporting | |
| Agreement State | |
| Time - Person (Reporting Time:+32.58 h1.358 days <br />0.194 weeks <br />0.0446 months <br />) | |
| Opened: | Tristan Hay 15:35 Jun 8, 2022 |
| NRC Officer: | Ernest West |
| Last Updated: | Jun 16, 2022 |
| 55933 - NRC Website | |
Inw Multicare Health with Agreement State | |
WEEKMONTHYEARENS 559332022-06-07T07:00:0007 June 2022 07:00:00
[Table view]Agreement State Underdose to Treatment Site 2022-06-07T07:00:00 | |