AGREEMENT STATE REPORT - EQUIPMENT FAILED TO FUNCTION AS DESIGNED
The following was received by email from the Commonwealth of Pennsylvania:
"On Friday, June 14, 2019, the licensee experienced an equipment failure event during a brachytherapy treatment where the source failed to retract from the patient at the end of the treatment time. The catheter was immediately manually removed from the patient and placed in the emergency container and locked up. No harm is expected to the patient and no overexposures occurred. The HDR [High Dose Rate] unit, an Elekta Flexitron Model 136149A02, contained an iridium-192 source less than 12 Curies. The vendor, Best Vascular, was immediately notified and will be on site today, June 17, 2019, to retrieve the source and repair the device.
"The DEP [PA Department of Environmental Protection] will update this event as soon as more information is provided.
"The DEP will perform a reactive inspection. More information will be provided as received."
PA Event Report ID No: PA-190014
* * * UPDATE FROM JOHN CHIPPO TO OSSY FONT ON 6/19/19 AT 1002 (EDT) * * *
The following information was received from the DEP via fax:
"On Monday, June 17, 2019, a service engineer from Best Vascular was able to drive the sources into the catheter and retract them into the device several times without incident. The licensee now believes the CVBT [CardioVascular BrachyTherapy] catheter was not fully seated into the device, causing a small leak and a subsequent pressure differential which does not allow the source to fully retract into the device."
The cause of the event is believed to be operator error. The DEP will perform a reactive inspection.
Notified R1DO (Greives) and NMSS Events Notification 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. |