Heart surgery patients across the U.S. are in danger from contaminated heater-cooler devices.
Know your risk – and your rights.
If you had open-chest surgery, you may be at risk of developing a life-threatening infection. A popular type of heater-cooler device called Stöckert 3T, that is used in many heart surgeries in the United States, has been contaminated. The bacteria grows so slowly that it can take years to detect signs of the infection. All the while, the bacteria can harm your health.
How do you know if you’re at risk?
The Scary Heart Surgery Infection Warning Letter
For many heart surgery patients, a frightening letter was the first sign that something might be wrong. Any infection symptoms you experienced might have seemed normal, given the stress your body has been through. After all, you’re recovering from heart surgery. That’s not easy.
Then you received a letter from the hospital where you had surgery warning of the heater-cooler infection risk. Just when you thought you had overcome the many risks associated with heart surgery, you learned that you’re still in danger.
The Challenges of an NTM Infection
It is difficult to know for sure if the device used in your surgery carried the bacteria. Current tests for contamination “are neither reliable nor timely,” the Centers for Disease Control and Prevention (CDC) reported. The notification letter you received from your hospital should tell you how many patients have developed this infection so far. Even if your hospital reports no known cases at this time, that doesn’t mean you’re out of the woods. It is very possible that an infection went misdiagnosed or simply hasn’t yet begun to present symptoms.
The warning letter refers to the bacteria, known as Mycobacterium chimaera or nontuberculosis mycobacterium (NTM), as “a rare bacterial infection.” Yet the small number of cases doesn’t change the reality that patients can and do lose their lives to this infection.
NTM infection isn’t just rare, it can also take years to present symptoms. The condition is “difficult to diagnose,” most hospital letters about heater-cooler infection warn. That makes getting appropriate medical care even more challenging.
Some hospitals have set up hotlines for patients to call if they have questions about contaminated heater-cooler devices. While calling this hotline may help you get answers to some of your questions, it won’t tell you everything you need to know. How was this dangerous exposure allowed to happen in the first place? Who is responsible? And what rights do you have if you did develop an infection?
What to Do If You Received a Heater-Cooler Infection Warning Letter
You got a heart surgery machine infection warning letter in the mail – now what?
The letter you receive will most likely urge you to watch for symptoms of an infection. It may direct you to call the hospital, or a special hotline number, with any questions. But you need better guidance than these vague instructions right now.
When NTM Infection Offers the Grounds for A Lawsuit
It’s not right that you have to go through all of this just because a negligent company made a contaminated surgical device. The manufacturer should be the one facing the consequences – not you.
This infection isn’t something that just happened due to bad luck or a poor medical outcome. These contaminated heater-cooler devices expose every heart surgery patient with whom they come into contact to the bacteria. The blame for this complication falls squarely on the maker of the device.
Now patients are fighting back against companies that create and sell heater-cooler devices contaminated with Mycobacterium chimaera bacteria. They are pursuing heart surgery infection lawsuits to hold the manufacturer accountable. In doing so, these patients can get compensation for all that they have lost because of the infection – their money, their health, and even the pain they suffered.
To move forward with a heater-cooler lawsuit, you need to first talk to a lawyer about your situation.
Contaminated Heater-Cooler Devices
How did this problem happen in the first place? That’s something the letter you receive from the hospital’s chief medical officer probably won’t tell you.
It starts with a company called LivaNova PLC. This company bought out another company, which used to be known as Sorin Group Deutschland GmbH. In its München, Germany, manufacturing plant, Sorin Group made a brand of heater-cooler devices sold under the trade name Stöckert 3T. These devices became contaminated with Mycobacterium chimaera.
Contamination happens during the manufacturing process, the CDC reported. Even the very first patients exposed to the devices were already at risk.
How Doctors Use Heater-Cooler Devices in Surgeries
Heater-cooler devices, sometimes called HCDs, do just what you would expect. They heat and cool patients as needed during surgeries. The use of HCDs isn’t about keeping patients comfortable. They’re needed to keep the body at the optimal temperature for the best medical results.
HCDs play a crucial role in cardiothoracic surgeries. These are operations that involve the heart or lungs. In a type of open chest surgery called cardioplegia, doctors stop the heart from beating so that they can better repair it.
During the time the heart is stopped, a heater-cooler device keeps the blood flowing throughout the body and maintains the temperature of organs, according to the CDC. Essentially, HCDs keep patients alive while their hearts are shut down and being worked on.
Some of the procedures in which doctors may use HCDs include:
- Aortic anomaly surgery
- Coronary artery bypass graft (CABG)
- Cardiopulmonary bypass surgeries
- Extracorporeal membrane oxygenation (ECMO)
- Heart transplant
- Heart valve replacement
- Left ventricular assist device (LVAD) implant
- Lung resection
- Lung transplant
- Pulmonary artery banding
How Heater-Cooler Devices Work
The Stöckert 3T Heater-Cooler devices have tanks to hold both cold and warm water as well as heat exchange coils. HCDs connect to a heart-lung machine. They perform a couple of different roles in an open heart surgery.
- Heater-cooler devices transmit the cardioplegia solution doctors use to stop the heart into the body, the Food and Drug Administration (FDA) reported.
- HCDs also facilitate the blood flow within the patient blood circuit.
- The water held in a heater-cooler device’s tanks is used in the external heat exchangers as well as warming and cooling blankets that help regulate a patient’s body temperature.
It’s in these water tanks that Mycobacterium chimaera can live. When these dangerous bacteria infect heart surgery patients, those patients and their families have the right to pursue a Stöckert 3T lawsuit.
How Stöckert 3T Heater-Cooler Infections Develop
The water housed in an HCD tank doesn’t come into direct contact with patients. But the nontuberculosis mycobacterium can spread in other ways.
Most LivaNova 3T Heater-Cooler lawsuits result from bacteria that’s spread through the air. Aerosolized NTM bacteria travels through the heater-cooler device’s exhaust vent – and directly into the patient’s opened chest.
As a heart surgery patient, another stress on your body is the last thing you need. Due to your condition, you may have a harder time fighting off dangerous bacteria than a healthy person would. While infections are a possibility in all kinds of surgeries, you’re more likely to suffer a serious infection following heart surgery if you were exposed to a Stöckert 3T Heater-Cooler during the procedure.
The companies that manufacture HCDs know the importance of medical device safety. After all, the products they create are used in patients who have serious medical conditions – often, patients whose ability to heal is compromised. LivaNova and Soren had a responsibility to ensure that their Stöckert 3T Heater-Cooler devices didn’t pose further risks to patients. They neglected to uphold this responsibility. That’s why patients are now moving forward with heart surgery infection lawsuits.
NTM Infection Symptoms
How will you know if you were one of the unlucky patients to develop a heart surgery infection due to an HCD?
Receiving a heart surgery machine warning letter is just one indication that you might be at risk. If you did receive a letter – or even if you didn’t – you should be on the lookout for heart surgery infection symptoms.
Symptoms of M. chimaera infection include:
- Muscle aches
- Night sweats
- Weight loss
The symptoms of NTM infection “are often general and nonspecific,” according to the CDC. If you notice any changes in health after open heart surgery, take them seriously. Make a point to bring them to your doctor’s attention. You never know which symptoms could be signs of a serious condition.
A post open heart surgery infection from NTM progresses slowly. It usually takes months before patients begin showing clear symptoms of an infection. Sometimes, it takes years.
How Common Are Cardioplegic Surgery Heater-Cooler Infections?
Every year, more than 250,000 U.S. patients undergo heart bypass procedures that involve the use of heater-cooler devices, the CDC reported. The Stöckert 3T Heater-Cooler devices linked to heart operation infections play a role in around 60 percent of these procedures. That means as many as 150,000 American heart surgery patients are exposed to potentially dangerous HCDs each year.
Most of these exposures don’t lead to a deadly cardioplegic surgery infection. But between one in 100 and one in 1,000 instances do, according to the CDC. Up to 1,500 heart surgery patients each year could contract Stöckert 3T Heater-Cooler microorganism infections.
If you develop an infection, the situation is serious. Non-tuberculosis mycobacteria infections kill almost 50 percent of patients who contract them.
It is inexcusable for a medical device manufacturer to put thousands of lives in danger this way. Already, dozens of patients and families have filed Stöckert 3T Heater-Cooler lawsuits. You can, too.
Heart Surgery Infection News Update
Cardiopulmonary bypass temperature controllers like the Stöckert Heater-Cooler have been the subject of recalls since at least 2007. Any Stöckert 3T device in use as of January 1, 2012, could be contaminated, the CDC reported.
However, it wasn’t until 2015 that anything was done about the danger. In July 2015, Sorin updated cleaning instructions for the device. Still, the FDA sent LivaNova a warning letter about the Stöckert 3T Heater-Cooler M. chimaera infections in late December 2015.
Even then, patients remained in the dark. Not until June 2016 did the FDA assemble a panel of experts to discuss notifying patients and testing devices for contamination. Many patients weren’t notified until late 2016 or even early 2017. By then, they may have been at risk of a serious infection for years.
It’s wrong that a medical device manufacturer put patients’ safety at risk. It’s even worse that it took years for patients to finally find out the truth.