A Pennsylvania Stockert heater-cooler lawyer can present you with legal options for patients who developed severe infections after having a surgical procedure with the device. Commonly used during cardiac surgical procedures, heater-cooler devices are used to warm and cool patients’ blood during cardiac pulmonary bypass. However, the devices have been associated with an increased risk of nontuberculous mycobacterium infections. Affected patients and their families may be able to file a lawsuit and pursue damages with the help of a Pennsylvania Stockert lawsuit attorney.
For more information, contact the Attorney Group for Pennsylvania today. We offer free, confidential, no obligation consultations. We can help answer your questions, and if you choose to pursue a case we can connect you with an affiliated Pennsylvania heater-cooler lawsuit attorney who can assist you throughout the legal process.
What is a Heater-Cooler System?
Heater-cooler systems are often used during surgical procedures to warm or cool patients. The devices are typically used for cardiothoracic surgeries involving the heart, lungs, esophagus and other chest organs. Heater-cooler systems consist of water tanks that provide temperature-controlled water to external heat exchangers or to warming/cooling blankets through closed water circuits.
Stockert 3T heater-cooler systems are intended to provide temperature-controlled water to patients who undergo cardiopulmonary bypass procedures that last six hours or less. Stockert 3T heater-cooler systems are manufactured by LivaNova PLC, and until October 2015, the devices were manufactured and distributed by the Sorin Group.
System Risks
A Pennsylvania Stockert attorney notes that a potentially fatal bacterial infection known as Mycobacterium chimaera (M. chimaera) has been linked to the use of heater-cooler devices, including the Stockert 3T heater-cooler system. A type of nontuberculous mycobacterium (NTM), M. chimaera can be found in the soil and water.
Symptoms associated with NTM infection include:
- Fatigue
- Vomiting
- Nausea
- Abdominal pain
- Redness, heat or pus at the surgical site
- Joint pain
- Weight loss
- Muscle pain
Although water used in heater-cooler systems does not come in direct contact with the patient, water contaminated with harmful bacteria could possibly enter other parts of the heater-cooler system or through the air by way of the device’s exhaust vent into the operating room and to the patient.
CDC and FDA Warnings
A number of warnings have been issued by the U.S. Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC) regarding the risk of infection related to the use of heater-cooler devices, including:
- October 2016 – The FDA releases an update to its June 1, 2016 safety communication to provide new information about M. chimaera infections associated with the use of Stockert 3T heater-cooler devices in U.S. patients who have undergone cardiothoracic surgical procedures. The new announcement includes recommendations for health care facilities and staff with regards to proper use and/or disposal of 3T heater-cooler systems.
- October 2016 – The CDC issues a report regarding M. chimaera contamination as well as a statement advising hospitals to alert patients who are possibly at risk from heater-cooler devices.
- May 2016 – The CDC issues guidance to help health care facilities identify patients with NTM infections related to the use of heater-cooler devices to ensure adequate diagnosis and treatment of affected patients.
- December 2015 – The FDA sends a warning letter to LivaNova PLC after inspections in Germany and Colorado revealed issues with Stockert 3T heater-cooler systems.
- October 2015 – The CDC sends a notice to health departments, health care facilities and individual health care providers regarding the need for increased action against NTM infections related to heater-cooler devices.
How a Pennsylvania Stockert Lawsuit Can Help
Medical device makers have a duty to provide safe products. If there are risks of harm associated with their devices, they also must provide adequate warnings. If a device maker fails to fulfill this duty, it could be held liable in lawsuits for injuries that may result.
People injured by a defective heater-cooler device may be eligible to recover money for:
- Medical Expenses
- Lost Wages
- Pain and Suffering
The families of those killed may be eligible to recover money for funeral expenses and the pain that comes with losing a loved one.
The Time You Have to Pursue a Claim is Limited. Contact Us Today.
For more information, contact the Attorney Group for Pennsylvania. You can fill out the form on this page or contact us by phone or email.
After you contact us, an attorney will follow up to answer questions that you might have. There is no cost or obligation to speak with us, and any information you provide will be kept confidential.
Please note that the law limits the time you have to pursue a claim or file a lawsuit for an injury. If you think you have a case, you should not delay taking action.
