Sorin 3t Heater Cooler Machines

This advice follows information indicating that some livanova plc formerly sorin group deutschland gmbh stöckert 3t heater cooler devices used during many open heart surgeries might have been contaminated during manufacturing which could put patients at risk for life threatening infections.

Sorin 3t heater cooler machines.

The centers for disease control and prevention found that some people who had developed infections died. Has a serial number starting with 16s. Lawsuits name the new company as well as u s. Sorin merged with cyberonics inc.

In 2015 federal investigators linked some of the machines to outbreaks of serious infections. The company s 3t heater cooler system regulates patients body temperatures during heart lung and other major chest surgeries. Lawsuits are currently being filed as a result of the infections caused by these products. The livanova 3t heater cooler system provides 3 circuits for fast and efficient heating and cooling to meet your patient and cardioplegia temperature needs.

In october 2015 to create a new company called livanova. Federal u s a law restricts this device to sale by or on the order of a physician. The sorin group originally manufactured the devices. All of the cases involve the use of the sorin stockert 3t heater cooler unit manufactured in germany.

Be aware of livanova s previous urgent medical device correction letters. You will sometimes hear the heater cooler unit referred to as the livanova stockert 3t system. The sorin 3t devices were originally branded as the stockert 3t heater cooler system. If using a livanova heater cooler system 3t that is not the new version i e.

Sorin 3t devices use independent water tanks and a compression based cooling system to keep patients at the desired temperature during surgery. Fda warning letter to livanova formerly sorin group s p a for its heater cooler 3t thermal regulator device after inspections conducted at facilities in munchen germany and arvada colorado. In 2015 sorin and another company merged to form a new company named livanova.