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
Heater-cooler devices are used in several types of open-heart surgical procedures. These include:
- Coronary artery bypass
- Heart transplants
- Pulmonary artery procedures
- Ventricular implants
So far, the CDC and FDA have only mentioned infections affecting people who have undergone open-heart surgery. However, patients who have had lung resection surgery, a lung transplant or a procedure involving the aorta could also be at risk.
The nontuberculous mycobacterium is not typically dangerous to a healthy person. In most cases, it is naturally expelled from the lungs. However, someone who has a compromised immune system could develop respiratory inflammation that can lead to severe infections. Because of the slow-growing nature of the infection, many people don’t realize they have it until it is too late.
No. It cannot be spread from person to person.
While the reason is unclear, certain forms of nontuberculous mycobacteria are much more resistant than others. Patients often have to take several different types of antibiotics simultaneously in order to treat the infection. Certain forms of the bacterium are easier to treat than others, such as M. kansasii. Others such as M. abscessus, M. chelonae and M. avium are more difficult. Surgery is sometimes needed in addition to antibiotics in order to remove diseased tissue or implants that have been affected.
According to The Cleveland Clinic, azithromycin, clarithromycin and rifabutin have shown to be effective in treating nontuberculous mycobacteria infections.
You may be able to file a wrongful death lawsuit for bacterial infection after surgery. Talk to an attorney as soon as you can to determine all of your legal options, as the terms that govern eligibility for filing a claim varies by state.
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:
- The 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.