ENS 51317
ENS Event | |
|---|---|
16:00 Aug 11, 2015 | |
| Title | Medical Event - Patient Received Underdose of Yttrium 90 |
| Event Description | During a treatment of the left lobe of the liver, the dose delivered to the patient was discovered to differ greater than 20 percent than the intended dose. 120 Gray was prescribed by the physician and 72 Gray was delivered. During the procedure the Rados meter did not appear to be operating properly. Subsequent investigation determined that there was some radioactivity that remained in the vial. The technologist called the manufacturer who advised to perform several flushes and the Rados meter still did not change. The procedure was ended at that point. After ending the procedure when the survey was performed on the waste jar, it was discovered that only 60% of the dose was delivered. The activity appeared to be concentrated in the plunger attached to the vial. A new Rados detector will be obtained prior to the next procedure.
The patient will be informed of the issue by the physician. Source Material: Yttrium 90, 7.03 GBq.
On 8/11/15, a left lobe liver Y-90 embolization was performed in the interventional radiology room at Middlesex Hospital. The Y-90 therasphere activity was 7.04 GBq on 8/2/15 at [12:00 EDT] and 0.696 GBq on 8/11/15 at 10:00 am. Prior to placing the vial containing the Y-90 into the dose calibrator, the nuclear medicine technologist turned and tapped the lead pot 90 [degrees] three times. The Y-90 was infused at 12:11 pm on 8/11/15. The prescribed dose to the target volume was 120 Gray. The device and assembly were set up according to the checklist provided by the manufacturer. The authorized user turned the lead pot containing the vial 90 degrees three times and then tapped it on the table twice. The Rados meter read 1.0 mR/hr when the seal was removed from the Y-90 vial and before the commencement of the embolization. After the first flush with saline (20 ml/min) the rados meter still displayed a reading of 1.0 mR/hr. Two further flushes failed to reduce the reading of 1.0 mR/hr. The authorized user requested that the company (BTG/Nordion) representative be contacted. The lead technologist was advised by phone by the BTG representative to have the physician repeat the massaging of the tubing where the Roberts clamp had been released and perform two (2) additional saline flushes. After performing the representative's suggestions the reading was still 1.0 mR/hr. Per the lead NM [Nuclear Medicine] technologist, the BTG representative had no further recommendations. The authorized user then lifted the plexiglass cover of the apparatus and tapped on the green plunger three times and replaced the cover and flushed one more time. The rados meter reading was still 1.0 mR/hr. The procedure was ended. Following post procedure measurements on the waste jar, the calculations showed that 60% (72 Gray) of the dose was delivered to the left lobe of the liver. Theraspheres may have been stuck in the vial and plunger. On 8/12/15, the Middlesex Hospital RSO/physicist measured the exposure levels from the separated out items in the waste jar. The highest reading was from the vial and plunger. The plunger was still attached to the vial. There is no anticipated adverse effect on the patient despite the fact that a lower dose (72 Gy) was delivered to the left lobe. Most of the patient's tumor burden is localized to the right lobe. Therefore, no additional Y-90 administration is necessary. Actions taken or planned: 1. BTG was notified. 2. The BTG RSO is working with the Middlesex Hospital RSO to determine the cause of the event. 3. In approximately 30 days, the Y-90 waste container will be sent to BTG for their investigation On 8/13/15, the patient and the referring physician were notified of the medical event. Notified the R1DO (Krohn) and NMSS Events (via 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. |
| Where | |
|---|---|
| Middlesex Hospital Middletown, Connecticut (NRC Region 1) | |
| License number: | 06-00649-03 |
| Organization: | Middlesex Hospital |
| Reporting | |
| 10 CFR 35.3045(a)(1) | |
| Time - Person (Reporting Time:+44.05 h1.835 days <br />0.262 weeks <br />0.0603 months <br />) | |
| Opened: | Joan Mertin 12:03 Aug 13, 2015 |
| NRC Officer: | Jeff Herrera |
| Last Updated: | Aug 25, 2015 |
| 51317 - NRC Website | |
Middlesex Hospital with 10 CFR 35.3045(a)(1) | |
WEEKMONTHYEARENS 513172015-08-11T16:00:00011 August 2015 16:00:00
[Table view]10 CFR 35.3045(a)(1) Medical Event - Patient Received Underdose of Yttrium 90 2015-08-11T16:00:00 | |