A popular device used in heart surgery, a cardiac heater-cooler device, is now under criticism because of cases of serious bacterial infection as a result of its use.

The cardiac heater-cooler, a device used in heart surgery, has been around in some form since the 1960s. It looks like a portable air conditioner, but can be vital for the health and recovery of a heart surgery patient.

This device used in heart surgery contains tanks of water that is circulated through narrow tubes. These devices are used to regulate the body temperature of a patient during heart bypass surgeries and heart-valve replacements as well as other cardio-vascular operations.

For many years, cardiac heater-coolers were thought to be very safe because the non-sterile water never comes in contact with the patient.

However, in the Stockert 3T cardiac heater-cooler made by LivaNova, it has been discovered that bacteria from the water sometimes leaks into other parts of the device used in heart-surgery. When this happens, and the bacterial multiply they can get dangerously close to the heater-cooler’s exhaust fan.

The exhaust fan has the potential to spray this bacteria throughout the sterile operating room, putting the patient at risk for infection.

Non-tuberculosis mycobacteria (NTM) is the most common form of bacteria that has been infecting heart surgery patients recently in connection with the heater-cooler devices. This bacteria is found usually in soil and not normally in hospital settings.

According to Consumer Reports, in 2014 a South Carolina man died from an NTM infection after a heart surgery. At the time, it was not known that his infection was connected to a device used in heart surgery. But after his death, the same rare bacteria infected 14 other patients in the same hospital which resulted in 3 additional deaths.

The South Carolina Public Health Department found that the infection was linked to a device used in heart surgery, a heater-cooler device.

Since that time, the U.S. Food and Drug Administration has received many reports of similar incidents connected to this device used in heart surgery. From 2010 to 2016 the FDA took note of 180 infection reports regarding cardiac heater-coolers internationally.

At least 16 hospitals in the U.S. were represented in a FDA report as well as 45 U.S. patients, including 9 deaths.

Most of these adverse event reports have to do with the Stockert 3T cardiac heater-cooler manufactured by LivaNova.

Both the CDC and the FDA have issued warnings to hospitals to check for NTM in heart surgery patients and take increased measures to safeguard against bacterial spread from their heater-coolers.

One of the problems with NTM detection is that the bacteria grows very slowly. It can, at times, take years for NTM bacterial symptoms to emerge, so doctors may not connect the infection with previous heart surgeries. Also, it is quite rare, so doctors may not even know to look for it.

If you or someone you love has been diagnosed with an infection after heart surgery because of a device used in heart surgery, you may be entitled to legal compensation.