Defective Heater-Cooler Device Has Caused Infections and Deaths in Patients

When a patient undergoes certain types of cardiothoracic surgery, they are often connected to a heater-cooler device that warms or cool patients during the procedure. These devices contain temperature-controlled water tanks that send heated or cooled water to warming or cooling blankets through a closed circuit (the water does not come into contact with the patient’s body).

Cardiac patients have contracted rare infections which have been linked to the heater-cooler devices. Approximately 500,000 patients who have had surgery that involved a heater-cooler device could be at risk of developing the potentially dangerous nontuberculous mycobacteria infection (NMT). The U.S. Food and Drug Administration (FDA) has received about 180 incident reports about adverse incidents with heater-cooler devices. Among those adverse reports, 45 patients had developed an infection. There were nine deaths reported in 16 hospitals in ten states that have been linked to the Sorin Stockert 3T Heater-Cooler Device.

Apparently, the devices in question were manufactured in Germany, and were contaminated with bacteria during the manufacturing process. In the affected devices, the bacteria grow in the water tanks and become airborne as the water evaporates into the air, which the patient then inhales. Patients who have gone through cardiothoracic surgery have compromised immune systems, which can make it challenging for their body to fight off the infection when they are exposed to it. The defective medical devices include the Stockert 3T Heater-Cooler, which are manufactured by LivaNova PLC in Germany. In 2015, the FDA sent a warning letter to the Sorin Group Deutschland GmbH (the former name of LivaNova) with the results of their inspection of the company’s facilities, and what changes they needed to make in order to be in compliance with FDA safety standards.

Nontuberculous Mycobacterium Infection symptoms

One of the challenges is the long incubation period of the infection. Symptoms may not appear for months or years after exposure, and the symptoms are the same as many other common illnesses:

• Fatigue
• Unexplained fever
• Sudden weight loss
• Night sweats
• Muscle aches

In June of 2016, the FDA issued a Safety Communication about Mycobacterium Chimaera Infections which have been associated with these heater-cooler systems with instructions for health care facilities and staff in facilities that use heater-cooler devices and recommendations for patients who have had cardiopulmonary bypass surgical procedures that have used a heater-cooler device.

The FDA and CDC have notified hospitals about the risk of infection with the defective devices and hospitals are notifying patients of the potential risks of having possibly been exposed to the harmful bacteria during surgery, and the U.S. Veteran’s Administration is offering free testing for those who might have been exposed to the bacteria during cardiothoracic surgery.

The infection can be treated with a powerful antibiotic, but those whose symptoms are left untreated can become seriously ill and deaths have occurred from NMT infections.

If you know that you have had open chest surgery in the past five years you might consider contacting your doctor and hospital to see if you are at risk for infection from a defective heater-cooler device.