LivaNova PLC is facing a new product liability claim from a Florida woman, alleging her husband died from an infection directly caused by the company’s Stockert 3T heater cooler.

The woman alleges that not long after the Stockert 3T heater cooler was used during a procedure, her husband developed a deadly infection and ultimately died from it.

Plaintiff Melanie R. is filing this cardiac heater cooler infection lawsuit on behalf of Michael M., who allegedly died in direct result of the contaminated Stockert 3T heater cooler used during his open heart surgery.

As with many other patients, the Stockert 3T heater cooler system was used to help regulate Michael’s body temperature during surgery; the devices are commonly used for open heart surgeries. However many of these patients have reportedly developed bacterial infections soon after their procedure, reportedly due to the cardiac heater cooler systems being contaminated.

This was allegedly the case with Michael, who had undergone open heart surgery on Jan. 27, 2017, with a Stockert 3T heater cooler being utilized during the procedure. Not long after the procedure, Michael developed a serious bacterial infection; he later died from the ailment, according to Melanie’s complaint.

Melanie opted to file legal action on her husband’s behalf, after learning of several warnings from the FDA and the CDC regarding the Stockert 3T heater cooler. The warnings stated that models of the Stockert 3T heater cooler manufactured by LivaNova before September 2014 may be contaminated with potentially fatal nontuberculosis mycobacterium (NTM).

This bacterium naturally occurs in the environment and is found in soil or water, but can be deadly in rare circumstances.

Overview of Stockert 3T Heater Cooler Problems

The Stockert 3T heater cooler system consists of two temperature controlled water tanks, which do not make direct contact with the patients and are used to regulate body temperature. This device is considered very important in the medical community, because it keeps organs and blood at proper temperatures while patients are under anesthetic.

Even though the two water tanks do not make direct contact with the patient, the FDA warns “there is the potential for contaminated water to enter other parts of the device and aerosolize.” This means the bacteria can become airborne, and escape into the surgical environment through the device’s exhaust vent.

The FDA and CDC stated that Stockert 3T heater cooler systems manufactured before September 2014 may be contaminated with M. chimaera bacteria, which was discovered by inspectors while conducting testing in their manufacturing plant in Germany.

While the contamination was reportedly resolved in July 2015, healthcare facilities and professionals are still warned that devices manufactured before September 2014 could pose a deadly risk for patients.

The FDA first warned against this issue in October 2015, stating it had received 32 Medical Device Reports from patients who developed infections allegedly from cardiac heater cooler devices.

However the FDA did not specify that it was the Stockert 3T heater cooler system until July 2016, and later provided health officials with recommendations on how to prevent the spread of infection. It is important to note that M. chimaera bacterial infections can take months or even years to develop, often resulting in latent diagnoses.

Even though M. chimaera infections can be potentially deadly to patients, LivaNova PLC allegedly failed to warn the general public in a timely manner.

This Stockert 3T Heater Cooler Lawsuit is Case No. 9:18-cv-80401-RLR, in the U.S. District Court of Southern Florida, West Palm Beach Division.