Plaintiff Michelle T., who has filed individually and on behalf of her minor daughter, has initiated an open-heart surgery infection lawsuit against LivaNova, the manufacturers of a cardiac heater cooler that is frequently used in surgery.

The purpose of the heater cooler device is to maintain the patient’s body temperature during surgery. Unfortunately, however, a number of patients have had to initiate legal action due to the development of an open-heart surgery infection, allegedly caused by the device.

Those patients who have suffered a mycobacteria infection after open-heart surgery might have grounds to pursue a lawsuit against the manufacturers of the heater cooler system. The medical device can potentially cause a patient to suffer an open-heart surgery infection if and when contaminated air from the machine travels into an open body during the course of surgery.

Stockert 3T is the manufacturer of the heater cooler device and it has been associated with numerous different claims of infection development.

Stockert 3T Heater Cooler

The heater cooler medical device was approved through the FDA’s 510(k) program; this program requires much less stringent requirements and fewer clinical trials than traditional FDA market approval.

In 2014, however, the manufacturer of the heater cooler device first received a health professional report that at least one patient had experienced an open-heart surgery infection after a procedure in which the Stockert 3T device was used. An adverse event report was filed with the FDA in February 2014 as a result of those reports.

Fifteen additional patients tested positive for a mycobacterium (NTM) infection which was included in a report given to LivaNova in June 2014.

Infection Risks

According to the open-heart surgery infection lawsuit, the manufacturers of this device knew or should have known about the devastating risks of infection development. As infection is always a possible side effect after going through any surgical procedure, a person should always be warned about the possible dangers and the symptoms to watch for that could indicate a life-threatening infection.

Many plaintiffs who have filed open-heart surgery infection lawsuits against the Stockert 3T manufacturer say that they were never warned about the possible side effects or the fact that the device was connected to a higher rate of infection to begin with.

The open-heart surgery infection lawsuit accuses the defendants of multiple breaches including failure to ensure safe use of a Stockert 3T, failure to warn about the dangers of the use of the Stockert 3T, and failure to manufacture the Stockert 3T device to avoid unreasonable risk of harm.

When contaminated air particles get into the body of a patient during surgery, the consequences can be dire. A person who went through surgery some time ago might not even know that their current infection is linked to a previous procedure. If you or someone you know has already developed an infection as a result of this medical device, you may be eligible to file a lawsuit against the maker of the heater cooler device.

The Open-Heart Surgery Infection Lawsuit is Case No. 2:18-CV-06415-NJB-MBN, filed in the United States District Court for the Eastern District of Louisiana.