ENS 49268

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v t e ENS Event
16:38 Jan 31, 2013
Title	Agreement State - Equipment Failure Resulted in No Prescribed Dose Delivered to Patient
Event Description	The following report was received from New York City via email. Summary: Zero percent of prescribed dose delivered due to patient catheter occlusion. Details of the incident: On January 31, 2013 a male patient, 83 years of age, was scheduled to receive Theraspheres treatment in Interventional Radiology. The patient has a history of hepatitis C and hepatocellular carcinoma (HCC) with multiple HCC tumors in the liver, progressive in spite of previous chemoembolization and radiofrequency ablation therapy, was referred by oncology for Yttrium-90 microspheres therapy. At the time of a nuclear medicine consultation of December 21, 2012, it was determined that the patient is a candidate for Yttrium-90 (Y90) Therasphere therapy, the preferred radioembolization agent (device) for HCC. A lung shunt fraction of 3.3% (predetermined), and a desired dosimetry of 120 Gray, the Y90 Therasphere activity of 3.83 GBq was ordered for the patient. Interventional Radiology Physicians placed a 0.021 inch microcatheter, inside of a Sarah 5 Fr. Radial catheter, via the left radial artery, into the right hepatic artery, into the same position as during the January 11, 2013 diagnostic study. When the catheter was in place, a Y90 Therasphere administration kit was brought into position for dose delivery. The administration kit was prepared by the Authorized User according to standard operating procedure, using a manufacturer's checklist. The delivery line was connected to the angiocatheter in the patient's arm. Just prior to that, the catheter was first flushed with IV contrast to ensure position, followed by flushing with normal saline, and then connected to the Therasphere kit infusion line. The infusion was started at 12:18 PM [EST] by Interventional Radiology Physician and the Authorized User, according to standard protocol, with sufficient pressure applied to result in periodic drops of saline dripping into the pressure relief bottle. At the end of the first 20cc bolus of saline, the reading on the radiation meter outside of the container failed to drop to 0.0 as usual. This was an indication that most of the radioactivity was still present in the vial. There were 10 more attempts to infuse the activity. In spite of additional attempts, only some of the Theraspheres moved forward into the catheter. The infusion attempt was terminated at 12:38 PM. At that point, the catheter was disconnected, taking care not to spill any contents inside. Towels were positioned under the catheter opening, a syringe was connected directly to the catheter, and an attempt was made to flush the catheter, but it was not possible, as it was blocked. At this point the catheter was withdrawn from the patient, and was placed together with the connecting line, dose vial and infusion kit container into a plastic bag for containment. The Interventional Radiology Physicians and the Authorized User underwent the standard survey procedure for removal contamination, the outer gloves were surveyed. Indicating some activity. The gloves were removed and placed into the administration box. The booties were removed and the principles stepped away after testing negative for contamination. The absorbent lining, which was wet from the infusion saline over-flow and box platform supporting the infusion kit, was also placed into a plastic bag. The floor absorbent mat was rolled up and also placed in a plastic bag, and replaced with a new floor mat to allow patient transfer onto a stretcher. The patient sterile covering was also rolled up and placed in a plastic bag. Both the Nuclear Pharmacist and the Nuclear Medicine Technologist were surveyed and found free of contamination. Once the plastic bags with the infusion materials were removed from the immediate area and the patient taken for imaging in nuclear medicine, the procedure room (Number 1) was surveyed by the Radiation Safety Office staff and was declared free of removable contamination and cleared for routine clinical use. The patient underwent a whole body scan in Nuclear Medicine, but was found to have no radioactivity in his body. A survey of all the plastic bags with the materials involved in the procedure, revealed that all the activity was contained in one bag (containing the catheter, administration set and dose vial), independently documenting that the patient received no Y90 activity. Corrective action taken by the facility: Facility is working with the manufacturer to determine the cause of the incident. Corrective action will not be developed until the manufacturer determines what was the cause of the failure to deliver the prescribed dose. How was it discovered: The physician discovered the event when the reading on the radiation dosimeter outside of the delivery system failed to drop to 0.0 mR/hr as usual. Causes/Contributing Factors: Equipment malfunction. Equipment used: NORDION TheraSphere Administration Accessory Kit Part #: K125914-001 -RADOS Model: RAD 60R Personal Dosimeter -Fluke Victoreen Ion Chamber Model: 451B-RYR-SS -0.021" Microcatheter and a Sarah 5 Fr. Radial Catheter RSO's review summarization: The Radiation Safety Office was notified on January 31, 2013 at 12:40 PM that an incident had just occurred in the Interventional Radiology suite which may have resulted in contamination. The RSO staff immediately responded to the location and was informed of the details of the event by the Authorized User. The Authorized User had already collected all of the equipment associated with the Y-90 infusion kit in a large plastic bag which was on a cart. The RSO survey of this cart indicated that the entire dose activity was still within the infusion kit and associated delivery tubing. Thorough survey of the patient, floor, table, hands and feet of staff (who had remained in the room waiting for RSO arrival) did not find any contamination. The whole body scan of the patient confirmed that no radioactive material was injected into the patient. The RSO immediately informed the local regulatory authority by phone followed by a written report of the incident. The Authorized User contacted the manufacturer of the radiopharmaceutical and infusion kit and requested an engineer to come to the medical center to determine the cause of the incident. The referring physician also was informed. On February 6, 2013 an inspector from the local regulatory authority visited the medical center and reviewed the incident. At the conclusion of this meeting the inspector collected all the documentation including the Standard Operating Procedure and training materials to investigate further to see if this incident was a Medical Event since 0% of the prescribed dose had been administered. The inspector also requested that a date be scheduled where they could witness kit preparation as well as an actual patient procedure. The engineer from the manufacturer was in contact with the Authorized User and agreed to come to the medical center to examine the used equipment associated with the Y -90 infusion kit to reveal the cause of the incident. The patient and referring physician have been notified. 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.

ENS 49268 +/-
Where
Mount Sinai Medical Center New York City, New York (NRC Region 1)
License number:	NOT PROVIDED
Organization:	Nyc Office Of Radiological Health
Reporting

Agreement State
Time - Person (Reporting Time:+4631.45 h192.977 days <br />27.568 weeks <br />6.344 months <br />)
Opened:	Tobias Lickerman 15:05 Aug 12, 2013
NRC Officer:	John Shoemaker
Last Updated:	Aug 12, 2013
49268 - NRC Website
v • d • e

v t e Emergency Notification System
Mount Sinai Medical Center with Agreement State
WEEKMONTHYEAR2025-02-26T04:00:00 [Table view]
[ENS list for Mount Sinai Medical Center]

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