Stockert 3T Heater-Cooler Lawsuits

Flaws in the Stockert 3T Heater-Cooler System used in heart-bypass operations have led to serious infections and at least 12 deaths, according to the files of the Food and Drug Administration, the national overseer of drugs and medical devices.

This serious health risk has been acknowledged by the FDA in warnings to patients and health care professionals and spawned numerous Stockert 3T Heater-Cooler lawsuits across the country.

If you or a loved one suffered a non-tuberculous mycobacterium (NTM) infection or other serious health issue from a Stockert device there is legal help available through the national network of specialized lawyers at Injury Help Desk.

Free case evaluations are being offered now but there may be legal time limits that could adversely affect your right to collect damages in Stockert NTM lawsuits so please contact us at Injury Help Desk as soon as possible to review all of your legal options.

WARNING: In cases of such infections, of course, the first thing any patient suffering from side effects due to a compromised immune system after such an operation should do is immediately contact a physician.

The heater-cooler device was first approved by the FDA in 2006 and national health statistics show that it has been a component in more than 250,000 heart bypass operations with the vast majority of those involving the Stockert 3T.

The FDA says heater-cooler devices are used during cardiothoracic surgeries, as well as other medical and surgical procedures to warm or cool a patient to optimize medical care and improve patient outcomes.

Heater-cooler devices include water tanks that provide temperature-controlled water to external heat exchangers or warming/cooling blankets through closed circuits, the agency says. That’s where the contamination factor comes in, according to the FDA:

“Although the water in the circuits does not come into direct contact with the patient, there is the potential for contaminated water to enter other parts of the device or transmit bacteria through the air (aerosolize) through the device’s exhaust vent into the environment and to the patient.”

WHAT ARE THE ALLEGATIONS IN A STOCKERT 3T LAWSUIT?

Attorneys, such as those in the national network of specialized lawyers available through Injury Help Desk are investigating claims that heart-bypass victims suffered life-threatening infections and deaths as a result of defective heater-cooler systems.

Among the allegations common to a Stockert 3T heater-cooler lawsuit are the following:
  • The devices were defective.
  • The devices were inadequately tested.
  • The manufacturer hid problems from the FDA.
  • The manufacturer knowingly marketed the product despite being aware of the problems.
  • The manufacturer failed to adequately warn health care professionals of the dangers.
  • The manufacturer failed to adequately warn patients about the dangers.

The FDA also has alerted patients and health care professionals that heater-coolers from other manufacturers may be at risk, also:

Through the FDA’s analysis of adverse event reports, the medical literature, and information from national and international public health agencies, we are aware that the use of heater-cooler devices has been associated with Nontuberculous Mycobacteria (NTM) infections, primarily in patients undergoing cardiothoracic surgical procedures. NTM organisms are widespread in nature and can be found in soil and water, including tap water sources. They are typically not harmful, but in rare cases may cause infections in some patients.

The FDA is collaborating with professional societies, public health partners, heater-cooler manufacturers, and experts to evaluate additional strategies for mitigating infections associated with heater-cooler devices.

Our current analyses have identified potential root causes of contamination from heater-cooler devices, which include:

  • NTM bacteria transmitted through the air (aerosolization)
  • Laminar flow disruption
  • Heater-cooler design

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