The manufacturer of a heater-cooler system recently requested that the cardiac surgery infection lawsuits leveled against it be transferred and consolidated into one court.

Surgical equipment maker LivaNova filed the motion for consolidation of lawsuits regarding the Stockert 3T system with the U.S. Judicial Panel on Multidistrict Litigation (JPML). Consolidation would transfer all lawsuits filed in federal court, both pending and forthcoming, into one court.

According to some of the cardiac surgery infection lawsuits, patients developed serious, infections that were even resistant to antibiotics, allegedly due to contaminated 3T system devices. Other patients may not yet have been diagnosed with such an infection, but are being monitored for signs because they may have been exposed to one of these contaminated devices.

The number of cardiac surgery infection lawsuits has nearly tripled in the last several months, according to the defendants.

The U.S. Food and Drug Administration (FDA) has warned that surgery with a contaminated heater-cooler device could lead to a serious infection known as nontuberculous mycobacterium (NTM) infections. The Stockert  3T heater-coolers are capable of spreading contaminated water into the surgical room. In an open-chest surgery, this could have serious consequences.

The FDA released a new safety communication to healthcare professionals about this danger. The FDA advised medical professionals to “strongly consider transitioning away from the use of these devices for open-chest cardiac surgery until the manufacturer has implemented strategies for these devices to mitigate the risks of patient infection.”

Basics of Heater-Cooler Devices

Heater-cooler devices are used during heart surgeries to regulate the patient’s body temperature, warming and cooling the blood as necessary. These devices use temperature-controlled water to send to warming and cooling blankets, or to other surgical equipment.

Unfortunately, there is a possibility that the interior of the device could become contaminated with NTM and transfer bacteria to the patient. The water inside the device doesn’t make direct contact with the patient, but contaminated water may be able to move through other parts of the device or even aerosolize (that is, move through the air) through the exhaust vent toward the patient.

Patients may not even develop symptoms of the infection after heart surgery for months or even years after the initial exposure. Indeed, reports show that the average cardiac surgery patient linked with heater-cooler contamination failed to show symptoms of infection after heart surgery for up to three years.

Heater-cooler devices are manufactured by a number of companies, including Livanova. The Stockert 3T device was recalled by the FDA in July 2015 due to the “potential colonization of organisms, including Mycobacterium.”

A growing number of patients are filing cardiac surgery infection lawsuits over allegedly contaminated devices used during surgery.

Joining These Cardiac Surgery Infection Lawsuits

If you or someone you love has suffered from a serious infection after heart surgery with the use of a heater-cooler device, you may be able to join the growing number of cardiac surgery infection lawsuits.

While filing a lawsuit cannot take away the physical and emotional effects of such a serious infection after heart surgery or bring a loved one back to life, it can help to alleviate the financial burden caused by medical expenses and lost wages.