Heater-Cooler Device Information for Open-Heart Surgery Patients
The U.S. Centers for Disease Control and Prevention (CDC) and the U.S. Food and Drug Administration (FDA) recently informed all U.S. hospitals that there is a less than 1 percent chance that patients who had open-heart surgery may develop a rare bacterial infection related to a specific device used during their procedures.
According to the CDC, the exhaust air from a machine used throughout the United States during open-heart surgeries may have contained bacteria (Mycobacterium chimaera, a type of nontuberculous mycobacteria) as a result of contamination during manufacture of the device. The specific machine is the LivaNova PLC (formerly Sorin Group Deutschland GmbH) Stӧckert 3T Heater-Cooler System.
Following guidance from the CDC and the California Department of Public Health, Cedars-Sinai has evaluated information from all patients who have had open-heart surgery at the medical center dating back to Jan. 1, 2012. We have not found any cases of this infection to date.
We know that you and your family may have more questions about this issue. There is extensive information available through the CDC at https://www.cdc.gov/hai/outbreaks/heater-cooler.html and the FDA at http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/CardiovascularDevices/Heater-CoolerDevices/ucm492585.htm.
If you have additional questions or concerns, please contact your primary care doctor or call Cedars-Sinai at (424) 315-2255.