Heater cooler system 3t safety 2 2 cp ifu 16 xx xx usa 014 2 2 regulations and safety instructions 2 2 1 intended use in accordance with the applicable regulations the heater cooler is intended for use with a.
Sorin 3t heater cooler manual.
352 o because you did not notify the agency of your intent to introduce the device into commercial.
Has a serial number starting with 16s.
The device is primarily used for invasive surgeries involving the heart lungs esophagus and.
The stockert 3t device uses three tanks to circulate both heated and cooled water during invasive surgical procedures.
The stöckert heater cooler system 3t provides fast and efficient heating and cooling independent of the ice and water supply in the operating room.
Lawsuits are currently being filed as a result of the infections caused by these products.
Be aware of livanova s previous urgent medical device correction letters.
Covid 19 ecmo special supplement to package insert for us customers only remote access perfusion rap femoral venous cannula.
The sorin stockert 3t heater cooler system manufactured by livanova uses three circuits to simultaneously keep patients warm while also using cold water for cardioplegia the intentional and temporary cessation of cardiac activity during surgery.
The sorin 3t heater cooler system used during various types of heart and lung surgeries can spread a dangerous bacteria during the procedures causing serious infections illnesses and even death.
Sorin stockert 3t heater cooler the sorin stockert 3t heater cooler is a device manufactured by livanova a medical device company formed by the merger of cyberonics and sorin s p a.
The livanova 3t heater cooler system provides 3 circuits for fast and efficient heating and cooling to meet your patient and cardioplegia temperature needs.
If using a livanova heater cooler system 3t that is not the new version i e.
Stöckert sorin s3 s5 c5 heart lung machine and or any other heart lung machine featuring a.
Three water tanks provide separate settings for warm cardioplegia cold cardioplegia and patient temperature.