Heater Cooler Devices Notice

CDC Warns of Potential Risk of Infection from Heater-Cooler Device Used During Open Heart Surgery

The Centers for Disease Control and Prevention (CDC) is warning healthcare providers and patients about the potential risk of infection from certain devices used during open heart (open-chest) surgery.

Patients who have had open heart surgery should seek medical care if they are experiencing symptoms associated with infections, such as night sweats, muscle aches, weight loss, fatigue, or unexplained fever. This advice follows new information indicating that some LivaNova PLC (formerly Sorin Group Deutschland GmbH) Stöckert 3T heater-cooler devices, used during many of these surgeries, might have been contaminated during manufacturing which could put patients at risk for life-threatening infections.

More than 250,000 heart bypass procedures using heater-cooler devices are performed in the United States every year. Heater-cooler units are an essential part of these life-saving surgeries because they help keep a patient’s circulating blood and organs at a specific temperature during the procedure. Approximately 60 percent of heart bypass procedures performed in the U.S. utilize the devices that have been associated with these infections. 

CDC estimates that in hospitals where at least one infection has been identified, the risk of a patient getting an infection from the bacteria was between about 1 in 100 and 1 in 1,000.

Sacred Heart Hospital in Pensacola and Providence Hospital in Mobile are notifying patients who received open-heart cardiac surgery about the potential infection risk. So far, no patients who had heart surgery at our two hospitals have been identified as having any of the infections associated with Sorin 3T HCU machines. Additional materials related to this notification are included on this web page.

Questions and Answers

Information for Patients Notified of the Risk of Infection Related to Heater-Cooler Devices Used in Their Open Heart Surgeries

  • Why did I receive a letter?
    • You received the letter because of a national alert from the Centers for Disease Control and Prevention (CDC). The CDC has notified all hospitals of risk of infection linked to heater- cooler devices used for open heart surgeries. The bacterium associated with this infection is called Mycobacterium chimaera, a Nontuberculous Mycobacteria (NTM). Although we have not yet identified any infections related to these devices at our hospital, out of an abundance of caution, we are reaching out to all the patients that may have been exposed to these devices to ensure they are aware and seek medical attention if they have any related symptoms. Your safety is a top priority for us.
  • Why am I receiving this letter now?
    • We have sent a letter to all patients who underwent their surgeries up to four years ago (July 2012). The reason for our decision was based on the CDC recommendations. These infections may present months to years after the surgery (up to 3.5 years). The chances are even lower after two years, but we wanted to ensure follow-up.
  • What is the risk of infection?
    • Overall, the risk of infection is thought to be very low. In hospitals where at least one infection has been identified, the risk of infection was between approximately 1 in 100 and 1 in 1,000 patients. Initial information suggests patients who had prosthetic implants are at higher risk (for example, the patient had a valve replacement or graft). So far, we have not had any of these infections associated with Sorin 3T HCU machines identified at our hospital. It is possible you may not have had this specific device used during your surgery.
  • What are the symptoms?
    • The symptoms are not specific to Mycobacterium chimaera infection, but if present, your physician will need to evaluate you further to make sure you do not have it. The infection is very uncommon (resulting in <1% of the surgeries that used these devices). It is important for a physician to evaluate you for more common reasons for your symptoms. The symptoms may include:
      • night sweats
      • muscle aches
      • weight loss
      • fatigue
      • unexplained fever
      • redness or drainage from sternal wound site

If you do not have symptoms, no further action is needed at this point. We encourage you to continue regular follow-up visits or communication with your physician and notify him/her of any changes in your condition. If you have one or more of these symptoms, further evaluation will be needed.

Letter to Patient

A copy of the letter sent to patients

Letters were sent to all patients who underwent open heart surgery up to four years ago (July 2012). This letter was sent to inform patients about the potential risk of infection from certain devices used during their open heart (open-chest) surgery.

Letter to Healthcare Providers

A copy of the letter sent to physicians

Letters were sent to healthcare providers to inform them about the situation and to provide them guidance if an open-surgery patient seeks assistance regarding this issue.

Frequently Asked Questions

More frequently asked questions

Based on the information provided by Centers for Disease Control and Prevention (CDC), we have compiled a list of frequently asked questions and answers regarding this issue.