Stockert 3t Heater Cooler Device
The livanova sorin stockert 3t heater cooler system provides fast and efficient heating and cooling independent of the cold and water supply in the operating room.
Stockert 3t heater cooler device. The use of ntm contaminated stöckert 3t heater cooler devices in heart operations may increase the risk of these deadly infections by circulating the bacteria throughout the operating room. The stockert 3t device uses three tanks to circulate both heated and cooled water during invasive surgical procedures. 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. 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.
The livanova 3t heater cooler system provides 3 circuits for fast and efficient heating and cooling to meet your patient and cardioplegia temperature needs. Cleveland clinic will continue to monitor updates from the cdc and fda detailing the concerns on the stockert 3t heater cooler devices manufactured by livanova plc. The stockert 3t heater cooler system is a medical device that keeps your body temperature regulated during cardiac surgeries. The stöckert 3t devices at our hospital tested negative for m.
Heater cooler devices are machines used in almost all open heart or open chest bypass surgeries to regulate a patient s body temperature. In addition you ll be able to quickly change both the temperature of the patient and the cardioplegia using separate circuits. Sorin stockert 3t features. The fda issued a warning letter late last month to sorin group bit srn concerning issues with its stockert heater cooler 3t thermal regulator devices.
In general methods for sampling and microbiological testing of heater cooler devices for m. 14401 w 65th way arvada co 80004 3503. Sorin group usa inc. The centers for disease control and prevention cdc estimates the risk to be less than 1 percent.
The most commonly used model of heater coolers livanova s stockert 3t has been linked to the spread of bacteria called nontuberculous mycobacteria ntm. Chimaera are neither reliable nor timely. For additional information contact. Should we still notify patients.
The water tanks in the device can become contaminated with mycobacterium chimaera either at the manufacturing plant where the device is developed or the hospital where the surgery occurs. Centers for disease control and prevention cdc estimates that as many as 1 in 100 people could be affected by serious complications from an ntm. Cheri voorhees 303 467. Yes hospitals should still notify patients.