A Texas Stockert infection lawyer can help people who developed severe infections after having a procedure that used the device. Heater-cooler devices are used to warm and cool patients’ blood during cardiac pulmonary bypass procedures. Despite their widespread use in hospitals throughout the United States, heater-cooler systems, including the Stockert 3T, have been linked to an increased risk of serious infections. Affected patients and their families may be able to file a lawsuit and pursue damages with the help of a Texas Stockert heater-cooler lawsuit attorney.
For more information, contact the Attorney Group for Texas 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 Texas Stockert infection lawyer who can assist you throughout the legal process.
What is a Stockert Heater-Cooler System?
Orignially manufactured by the Sorin Group, Stockert 3T Heater-Cooler Systems are manufactured by London-based medical device company LivaNova PLC. The heater-cooler devices provide temperature-controlled water to heat exchanger devices or warming blankets to heat or cool a patient during cardiothoracic surgical procedures lasting less that six hours.
Stockert Heater-Cooler System Infection Risks
According to the Centers for Disease Control and Prevention (CDC) 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.
Possible signs and symptoms of NTM infection include:
- Fatigue
- Difficulty swallowing
- Persistent cough or cough with blood
- Fever
- Pain, specifically abdominal, joint or muscle pain
- Redness, heat or pus at the surgical site
- Night sweats
- Weight loss
- Nausea
- Vomiting
Potentially contaminated water used in heater-cooler devices does not come in direct contact with the patient, however, harmful bacteria could possible enter the open cavity of a patient through a process known as aerosolization.
FDA Warnings and Recommendations
As part of an ongoing U.S. Food and Drug Administration (FDA) investigation of NTM infections related to the use of Stockert 3T Heater-Cooler systems, the agency has updated its safety communication so that patients are aware of the risks associated with the devices. Specifically, the agency notes that it 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 System.
Likewise, the FDA issued a warning letter to the Sorin Group (now LivaNova PLC) stating that inspections conducted at the company’s facilities in Germany and Colorado revealed significant issues, such as quality system and premarket clearance violation.
According to the FDA, patients should be aware that, in the U.S., cardiopulmonary bypass procedures most often involve the use of a heater-cooler device. Also, the FDA has received reports of patient infections associated with the use of a contaminated Stockert 3T heater-cooler device.
Patients who have undergone a cardiopulmonary bypass procedure and are experiencing the signs of NTM infections are advised to contact their health care provider as soon as possible. Additionally, patients who have received a heart valve, graft, left ventricular assist device, or any prosthetic material or heart transplant could be at a greater risk of developing a serious NTM infection.
How a Texas 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 the Attorney Group for Texas. 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.
