A California Stockert infection lawyer may be able to assist patients who developed severe infections after having a procedure that used the device. Stockert 3T Heater-Cooler Systems are often used in open-heart surgery to keep patients warm or cool. However, contaminated devices have been linked to severe infections. Affected patients and their families may be able to file a lawsuit and seek compensation with the help of California Stockert heater-cooler lawsuit attorney.
For more information, contact Attorney Group for California 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 California Stockert infection lawyer who can assist you throughout the legal process.
What is a Stockert 3T Heater-Cooler System?
Used in cardiothoracic surgeries (procedures typically involving the heart, lungs, esophagus and other chest organs), heater-cooler systems, including the Stockert 3T, are used to warm or cool a patient in order to provide optimal care during those procedures. Manufactured by LivaNova PLC, the Stockert 3T Heater-Cooler System uses compressor-based cooling and three independent water tanks so that ice and water supplies are no longer needed in the operating room.
Stockert Heater-Cooler Infection Risks
While the water used in heater-cooler devices does not come into direct contact with the patient, there is a potential for contaminated water to enter other parts of the system and travel through the air (a process known as aerosolization), potentially transmitting harmful bacteria to the patient’s open chest cavity.
Since October 2015, when it issued a safety communication noting an association between nontuberculous mycobacterium (NTM) infections and the use of heater-cooler devices, the U.S. Food and Drug Administration (FDA) has continued to monitor and evaluate the causes and risk factors for the spread of harmful bacteria. Symptoms associated with NTM infections include:
- Fever
- Weight loss
- Cough
- Lack of appetite
- Night sweats
- Loss of energy
Although they are rare, NTM infections do occur, and specific combinations of antibiotics may be necessary to treat patients who become infected.
FDA Warnings
In its original safety communication, the FDA noted that the agency had received 32 Medical Device Reports of patient infections associated with heater-cooler devices or bacterial heater-cooler device contamination. Because NTM infections associated with heater-cooler devices are often overlooked for months or even years, it is possible that some cases have not been reported to the FDA.
As the FDA continues to evaluate and investigate the relationship between the use of heater-cooler devices, including the Stockert 3T Heater-Cooler System, and serious NTM infections, the agency has released additional safety communications to alert patients and health care providers. Particularly, the FDA issued a safety communication on October 13, 2016, which provided new information about NTM infections related to the use of Stockert 3T Heater-Cooler Systems in U.S. patients who have undergone cardiothoracic surgical procedures.
Other Warnings
In October 2016, the Centers for Disease Control and Prevention (CDC) issued a report noting that two patient clusters in Pennsylvania and Switzerland had been infected with Mycobacterium chimaera (M. chimaera) after having undergone open-surgery. According to the CDC’s report, over 250,000 procedures using cardiopulmonary bypass are performed in the U.S. each year, with approximately 60 percent of the U.S. market using Stockert 3T heater-cooler devices during these procedures.
How a California Stockert Infection Lawyer 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 Stockert 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 Attorney Group for California. 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.
