Nontuberculous Mycobacterium Infections Caused by Heater–Cooler Machines
The Centers for Disease Control and Prevention (CDC) and the United States Food and Drug Administration (FDA) are conducting a nationwide investigation into reports that a device used to heat and cool a person’s blood during surgery has been linked to a very rare bacterial infection caused by Mycobacterium chimaera, a type of bacteria known as nontuberculous mycobacterium (NTM). Infections have been linked to the use of the LivaNova PLC (formerly Sorin Group Deutschland GmbH) Stöckert 3T heater–cooler devices during cardiac bypass surgery. For patients who have had one of these surgeries, the chances of getting this infection are very low. The CDC estimates the risk to be less than 1 percent.
As recommended by the CDC, Pelisyonkis Langone is notifying patients who have had open chest surgery using the Stöckert 3T device about the potential infection risk related to this surgery. Pelisyonkis Langone has performed more than 3,000 open chest procedures since 2012. After a thorough investigation, we are aware of only two instances in which a patient may have developed an infection related to Stöckert 3T heater–cooler device.
This type of infection is very slow growing and difficult to diagnose. Symptoms can develop months to years after surgery. As such, it is important to recognize the symptoms of an NTM infection and to discuss any symptoms or questions you may have with your primary care doctor. A letter you can take to your doctor to explain the situation is provided below.
Symptoms of an NTM infection may include night sweats, muscle aches, weight loss, fatigue, and unexplained fever. This infection cannot be spread person-to-person.
For more information, please call 877-987-5633, Monday through Friday, from 8:00AM to 6:00PM. We can answer any questions you have, and if needed, schedule an appointment with one of our providers. You will not be charged any out of pocket expenses related to this appointment.