An Iowa Stockert infection lawyer may be able to assist people who developed severe infections after having a procedure that used the device. Commonly used during open-heart surgery, heater-cooler devices warm and cool patients’ blood and internal organs during surgical procedures. 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 an Iowa Stockert heater-cooler lawsuit attorney.
For more information, contact Attorney Group for Iowa 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 Iowa Stockert infection lawyer who can assist you throughout the legal process.
What is a Heater-Cooler System?
Heater-cooler systems are medical devices used to keep patients warm and/or cool during surgical procedures, particularly open-heart surgery. According to the Center for Disease Control and Prevention (CDC), more than 250,000 heart bypass procedures using the devices are performed in the United States every year. An essential part of these types of surgical procedures, heater-cooler systems are primarily responsible for keeping a patient’s blood and organs at a specific temperature throughout the procedure.
Stockert Heater-Cooler System Risks
In a press release issued by the CDC in October 2016, the federal agency is warning health care providers and patients about the potential risk of infection associated with some heater-cooler devices, specifically the Stockert 3T Heater-Cooler System manufactured by LivaNova PLC (formerly Sorin Group). Information has indicated that some of these devices may have been contaminated during manufacturing, and patients could be at risk for life-threatening infections, specifically from a species of nontuberculous mycobacterium (NTM) known as Mycobacterium chimaera (M. chimaera). It can take months for symptoms to develop in patients who have been exposed to the bacteria through open-heart surgery.
Symptoms associated with the infections include:
- Night sweats
- Muscle aches
- Weight loss
- Unexplained fever
According to the CDC, approximately 60 percent of heart bypass procedures in the U.S. use the Stockert 3T.
Additional FDA Warnings
In an ongoing investigation of NTM infections related to the use of Stockert 3T heater-cooler devices, the U.S. Food and Drug Administration (FDA) has updated its safety communication so that patients are aware of the risks associated with the devices. An Iowa Stockert heater-cooler lawsuit attorney notes that the FDA has received reports of patients in the U.S. who have been infected with M. chimaera after undergoing surgical procedures involving the Stockert 3T heater-cooler device.
There are a variety of ways the devices can cause the spread of infection, including:
- Air transmission – NTM bacteria can potentially grow in the water tank of the heater-cooler device. Although the water does not come in direct contact with the patient, there is the possibility for contaminated water to enter other parts of the device or transmit NTM through the device’s vents into the operating room and into a patient’s open surgical cavity.
- Laminar flow disruption – A study suggests that the device’s exhaust fan could disrupt the protective nature of the laminar air flow above the patient.
- Heater-cooler design – In some cases, these devices may not contain an air or water filter. These kinds of filters could potentially remove most NTM before reaching the patients, however, air filters may alter device safety or performance.
According to a safety communication issued by the FDA in October 2015, the agency received 32 Medical Device Reports (MDRs) of patient infections associated with heater-cooler devices between January 2010 and August 2015. In some cases, patients were not aware of there infections until months or years after the procedure.
How an Iowa 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 Iowa. You can fill out the form on this page or contact us by phone or email.
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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.