Sorin 3t Heater Cooler Manual
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.
Sorin 3t heater cooler manual. 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. 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. The heater cooler system 3t is also misbranded under section 502 o the act 21 u s c. Three water tanks provide separate settings for warm cardioplegia cold cardioplegia and patient temperature.
Sorin 3t heater cooler lawsuits. Stöckert sorin s3 s5 c5 heart lung machine and or any other heart lung machine featuring a. The stöckert heater cooler system 3t provides fast and efficient heating and cooling independent of the ice and water supply in the operating room. If using a livanova heater cooler system 3t that is not the new version i e.
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. Be aware of livanova s previous urgent medical device correction letters. The device is primarily used for invasive surgeries involving the heart lungs esophagus and.
The livanova 3t heater cooler system provides 3 circuits for fast and efficient heating and cooling to meet your patient and cardioplegia temperature needs. Covid 19 ecmo special supplement to package insert for us customers only remote access perfusion rap femoral venous cannula. Compressor based cooling and 3 independent water tanks eliminate the need for ice and water supply in the operating room providing separate settings for warm cardioplegia cold.