Warnings have been issued by the FDA and CDC to healthcare providers nationwide regarding the potential of patients to develop heart surgery infections linked to the use of heater-cooler devices during heart surgeries.

These medical devices have been used in more than 250,000 heart surgeries annually, so many individuals have the potential of having been exposed to a risk of heart surgery infections.

The cause of these heart surgery infections was the contamination of the heater-cooler devices during manufacturing by a bacteria that can enter the surgical incision and cause problems for the patient after several months or several years of having the slow-growing bacterial infection in their body.

The heater-cooler devices are used during heart surgery to warm and cool patients so that their temperature is stable during the procedure. This allows for more favorable surgical outcomes and reduces the risk of excessive bleeding during surgery. The device uses water to heat and cool the patient, though no water actually touches the patient at all.

Water vapor in the machine, however, can leave the machine and become airborne. Once it is airborne in the operating room, there is a chance that the bacteria harbored in the water mist can inhabit the patient’s body via the surgical incision.

The CDC currently estimates that a patient’s risk of developing a bacterial heart surgery infection is approximately between one in 100 and one in 1000. So far, approximately 28 patients have been identified as having developed bacterial heart surgery infections from contaminated heater-cooler devices.

With any device, there is the potential for patients to suffer from unintended consequences, and this is the case for patients developing heart surgery infections related to the use of the device.

It is believed that the heater-cooler devices in question, made by LivaNova, were contaminated with a bacterium known as Mycobacteria chimaera, a bacterial infection that is particularly concerning for patients who already have a compromised immune system.

Infection from this bacteria is quite rare, and many doctors do not even think to consider the infection by that particular mycobacteria unless they have a specific reason to do so.

Hospitals have been requested to review the records of patients who had open heart surgery to see if those same patients came in with symptoms that could be indicative of heater-cooler heart surgery infections.

Since the CDC and FDA have issued their warnings, surgical infection lawsuits have been filed against LivaNova stating that patients had not been properly informed of the contamination even though the manufacturer knew that it was a possibility back in December 2015.

The heater-cooler manufacturer has contacted hospitals to let them know about ways they can continue to use the medical device safely and reduce the risk of contamination. However, many hospitals are refusing to use the device and are purchasing alternative units to use during open heart surgery.

Filing a Lawsuit over Heart Surgery Infections

If you or a loved one has undergone open heart surgery where the LivaNova Stockert 3T heater cooler device has been used and then subsequently developed a heart surgery infection, you may be entitled to legal compensation for your injuries.

An experienced attorney can review your case at no charge to you and can help outline the potential legal options that are available for you to pursue.