What is a Heater-Cooler Device?
A heater-cooler unit is critically important to an invasive surgery because it helps keep the body’s organs at a safe temperature and also helps keep the blood circulating properly. About 250,000 surgeries are performed in the U.S. every year, and approximately 60 percent of them involve the use of a heater-cooler device.
One of the most popular is the Stockert 3T Heater Cooler System, manufactured by the German company LivaNova PLC, which was formerly known as Sorin Group Deutschland GmbH. LivaNova issued a heater-cooler recall for the Stockert 3T in July 2015 due to a risk of contamination if proper disinfection maintenance procedures are not performed per the manufacturer’s instructions.
The heater-cooler device stores water in a tank, and the water is kept at a particular temperature in order to heat or cool a patient’s blood or body as necessary. Many nontuberculous mycobacteria lawsuit plaintiffs, however, are alleging that the water in the device’s reservoir can become contaminated and spray into the air. A severe – possibly even fatal – infection can result. Patients who have experienced these complications are encouraged seek legal counsel to determine their eligibility to file a Heater Cooler infection lawsuit.
Symptoms of a Nontuberculous Mycobacterium Infection
The nontuberculous mycobacterium is relatively harmless most of the time. But if it invades the body of someone with a weakened immune system – such as someone who has just undergone an invasive surgical procedure – major problems can occur.
Even worse, the damage can take months or even years to manifest. The infection itself can be difficult to detect because symptoms often resemble more benign conditions. These symptoms include:
- Unexplained fever
- Sudden weight loss
- Night sweats
- Muscle aches
Treatment of an infection requires the use of powerful antibiotics because other types of antibiotics that are routinely used are not effective. It can also involve further surgery to remove infected implants (such as heart valves) or tissue, leading to added suffering as well as major medical expenses.
What the CDC and FDA Say
The problem of nontuberculous mycobacteria has caught the attention of both the Centers for Disease Control (CDC) as well as the U.S. Food and Drug Administration (FDA). Both agencies issued reports on the link between the bacterium and heater-cooler devices on October 14, 2016.
The CDC reported that while thousands of patients had been notified that they could be at risk of infections due to contaminated heater-cooler devices, the number who may have been exposed could be much larger. On the same day, the FDA issued a Safety Communication advising healthcare providers on ways to help reduce the spread of infections linked to the device.
Hospitals Notifying Patients of Potential Risks
According to an October 13, 2016 article in The Washington Post, about 15,000 patients in Iowa, Michigan and Pennsylvania have been notified they may be at risk for an infection due to an allegedly contaminated heater-cooler unit. All of these patients underwent some sort of procedure that involved opening the chest. So far, 12 patients in one Pennsylvania hospital have developed infections that, the newspaper reported, were “most likely linked” to contaminated devices. Six of them died. LivaNova, according to the FDA, has received complaints regarding nontuberculous mycobacteria complications dating back to 2014.
Heater-Cooler Lawsuit Q&A
How Baron & Budd Can Help
You might be able to file a nontuberculous mycobacteria lawsuit if you developed an infection after undergoing an open-heart procedure that involved the use of contaminated heater-cooler devices. Plaintiffs filing a lawsuit for bacterial infection after surgery are claiming that the manufacturers sold unsafe, defective products that allowed dangerous bacteria to spread in patients.
Heater-cooler lawsuit plaintiffs are making the following claims against manufacturers of the devices:
- They failed to warn healthcare providers and the public about the risks.
- They misrepresented the benefits and risks of the device.
- They negligently manufactured a defective product.
If you are interested in filing a nontuberculous mycobacteria lawsuit, Get started online or call Baron & Budd at 866-626-3371. A lawyer for bacterial infection after heart surgery will let you know your options and help you put together a plan of action.