Patients who have developed a surgical site infection after heart surgery might have been exposed to bacteria from a contaminated temperature control device.

When patients undergo heart surgery, a cardiac heater-cooler unit keeps blood and organs at a normal temperature. These devices use water to control the temperature. Even though the water does not come into direct contact with a patient, some water may escape through the machine’s exhaust in the form of a fine mist that can enter the air in the operating room.

The Stockert 3T Heater-Cooler System (also known as the Sorin 3T) is made by LivaNova (formerly Sorin Group Deutschland) in Germany, in a facility where inspectors discovered contamination with a rare non-tuberculosis bacteria known as Myobacterium chimaera (M. chimaera). In September 2014, tests at the manufacturing plant in Germany revealed the M. chimaera contamination.

Both the Centers for Disease Control and Prevention (CDC) and the Food and Drug Administration (FDA) have issued safety warnings because the Stockert 3T Heater-Cooler System has been linked to severe and even deadly infections.

The FDA says “there is potential for contaminated water to enter other parts of the device and aerosolize,” and the bacteria-laced water droplets can land in the patient’s open chest cavity.

Reports of Surgical Site Infection Sparked Investigation

By October 2015, the FDA had received 32 reports of patients developing a surgical site infection after a heater-cooler device had been used during surgery. The FDA narrowed the source to the Stockert 3T Heater-Coolers in June 2016.

The FDA warns that the M. chimaera bacteria can fester for months or even years before it becomes a noticeable infection.

States including Iowa, Pennsylvania and Michigan have reported surgical site infection victims dating back to 2011. The CDC has confirmed 28 M. chimaera infections. The FDA says at least a dozen patients may have died as a result of their surgical site infection.

Patients who have undergone heart surgery and subsequently experience night sweats, weight loss, fatigue, muscle aches or an unexplained fever should seek medical attention immediately. These are possible signs the body is fighting infection.

More than 250,000 open heart bypass surgeries are performed using cardiac heater-cooler units annually. Sixty percent of the devices are the Stockert or Sorin 3T heater-coolers that have been linked to the M. chimaera contamination.

Surgical Site Infection Lawsuits

Patients who developed a surgical site infection after open heart surgery have started to file lawsuits against the LivaNova and Sorin.  A class action lawsuit filed in Pennsylvania in 2016 alleges the company should have known the Stockert 3T Heater-Coolers were not prepared in a sterile environment and that patients potentially would be exposed to dangerous bacteria.

The CDC says thousands of patients in the U.S. have been notified that they were potentially exposed to bacteria from the contaminated heater-cooler machines.

In October 2016, the FDA recommended health officials use new accessories, tubing, and connectors with the heater-coolers. The exhaust fan should be directed away from the patient. At least one hospital has placed the heater-cooler unit in a different room entirely to ensure the mist does not reach the patient.