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Heater-Cooler Devices

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Heater-Cooler devices are used during cardiothoracic surgeries and other procedures to improve outcomes by ensuring patients maintain an appropriate body temperature. In October 2015, these devices were subject to a safety warning after numerous patients developed Nontuberculous Mycobacteria (NTM) infections following surgery that involved the use of a Heater-Cooler system. In June 2016, Stӧckert 3T Heater-Coolers were identified in a separate warning, after those devices were linked to reports of NTM infections (specifically M. chimaera) in patients who had undergone cardiothoracic surgeries.

What are Heater-Cooler Devices?

Heater-cooler systems include tanks that provide temperature-controlled water to:

• Oxygenator heat exchangers
• Cardioplegia (paralysis of the heart) heat exchangers
• Warming/cooling blankets

Although the water never comes into direct contact with the patient, contaminated water can potentially enter other parts of the device. Contaminated water can also transmit bacteria through the air via the Heater-Cooler’s exhaust vent.

According to the U.S. Centers for Disease Control and Prevention (CDC), 250,000 heart bypass procedures using Heater-Cooler devices are performed in the U.S. annually. These units aid in keeping a patient’s circulating blood and organs at a specific temperature during the procedure, and are considered an essential part of these surgeries.

FDA Heater-Cooler Infection Warnings

In October 2015, the U.S. Food & Drug Administration (FDA) issued a Safety Communication regarding a possible association between the use of Heater-Cooler devices and Nontuberculous Mycobacteria (NTM) infections.  Between January 2010 and August 2015, the FDA received 32 Medical Device Reports detailing either patient infections associated with the devices or bacterial contamination of a Heater-Cooler device. However, the majority of cases (25) were reported in 2015. Some reports described NTM infections related to cardiothoracic surgeries, but others did not specify a procedure. Eight of the cases were related to three events that occurred at healthcare facilities in the U.S. The remainder occurred overseas, mostly in Western Europe.

On June 1, 2016, the FDA issued a new Safety Communication regarding infections associated with Stӧckert 3T Heater-Coolers manufactured by LivaNova PLC, (formerly Sorin Group USA , a subsidiary of  Sorin Group Deutschland GMBH), following the publication of a study which suggested a direct link between these specific products and M. chimaera infections in European patients who had undergone open-chest cardiac surgery. The FDA noted that tests performed by the manufacturer in August 2014 found M. chimaera contamination on the production line and water supply at the 3T manufacturing facility.

M. chimaera is a type of NTM infection that may cause serious illness or death. The infection is difficult to detect because affected patients may not develop signs and symptoms for months to years after initial exposure.

In October 2016, the FDA updated its previous Communication, after testing conducted by the CDC strongly suggested a link between M. chimaera infections reported in the U.S. and the Stӧckert 3T Heater-Coolers.