Cardiac Heater-Cooler Device Lawsuits
Attorneys for Cardiac Heater-Cooler Device Claims
Have you undergone cardiac surgery within the last 5 years? Were you diagnosed with a nontuberculous mycobacteria (NTM) infection afterward?
Patients are filing lawsuits against product manufacturers Sorin and LivaNova, for infections they developed as a result of using the Sorin 3T Heater-Cooler System. In February 2018, 39 federal lawsuits from across America were combined into multidistrict litigation (MDL) in Pennsylvania federal court.
If you or a loved one has developed a nontuberculous mycobacteria (NTM) infection following the use of this device in open chest surgery, call (713) 932-0777 today. Speaking with an experienced product liability attorney will help you determine the best way to handle your claim.
What is a Cardiac Heater-Cooler Device?
Cardiac heater-cooler devices are frequently used during cardiac surgery to maintain the appropriate blood temperature. They are especially useful during cardiothoracic surgeries that involve the intentional and temporary stopping of the heart and lungs.
The device includes a water tank that separates warm and cold water; as well as, a heating and cooling unit that allows air to flow in and out. A heater-cooler device works by supplying hot and cold water to heart-lung machines and other medical devices necessary for controlling body temperature during surgery.
FDA Safety Communication and Recommendations for any Heater-Cooler Devices
In June 2006, the FDA approved the Stockert 3T Heater-Cooler System as a Class II device. According to their definition, Class II devices, “are higher risk than Class I and require greater regulatory controls.” Between 2010 and August of 2015, the FDA received numerous reports of patient infections from Heater-Cooler devices that were contaminated.
In February of 2018, they updated the available information for health care providers and staff regarding the use of these products. The beginning of the release read:
“There is the potential for organisms (including NTM) to grow in the water tanks of any heater-cooler device. Contaminated water from the heater-cooler device has the potential to aerosolize into the operating room during surgery. This may lead to infection, primarily in cardiovascular patients undergoing open-chest surgical procedures.
In select patients, the benefits of temperature control during open-chest cardiothoracic procedures generally outweigh the risk of infection transmission associated with the use of these devices.”
Heater-cooler device lawsuits are not as common as most product liability claims being made, but that doesn’t mean patients who develop this infection aren’t protected. Understanding your rights is the first step you can take to protect yourself, call (713) 932-0777 for more information.
Heater-Cooler Device Injuries
Plaintiffs who filed lawsuits against the Soring 3T Heater-Cooler System claim that the device caused a rare, slow-growing infection under the NTM umbrella.
Some individuals received a notice from the facility where they were exposed to these devices, warning them of the potential infection risk. NTM bacteria infections can cause a number of negative conditions to develop, including:
- Abdominal abscess
- Myocutaneous thoracotomy flap infection
- Sepsis or septic shock
Free Evaluation for Cardiac Heater-Cooler Device Claims
If you or a loved one has developed an infection due to the use of a cardiac heater-cooler device, you may be entitled to compensation for your damages. Call (713) 932-0777 for a free case evaluation with a product liability attorney.