Increased Risk Of Infections After Cardiothoracic Surgery
Heater-cooler devices are used during cardiothoracic surgery to keep the heart cool while doctors are operating on it, while at the same time keeping the rest of the body warm. These devices can become contaminated with bacteria. If the contamination is passed to a patient it can then cause deadly infections.
At Crandall & Pera Law, our team of experienced attorneys help clients throughout the region who are dealing with injuries because of preventable infections. We offer free consultations to listen to your story, answer your questions and explain available legal options based on the specifics of your case.
The Risks Of Contaminated Heater-Cooler Devices During Open-Heart Surgery
Heater-cooler devices are made up of water tanks and heating/cooling blankets. The water contained in the tanks of a heater-cooler device never touches the patient’s body; however, if there are bacteria on the device it can become aerosolized, carried through the air and land on the patient’s open chest with organs exposed to the air.
The FDA investigated, and traced the source of the contamination to a manufacturing facility in Germany. The FDA sent a warning letter to the manufacturer of the heater-cooler devices, LivaNova (formerly Sorin Group) letting them know that the company’s methods and controls used in the manufacture, packing, storage and installation of the devices were in violation of FDA standards.
Types Of Infections Associated With Contaminated Devices
The pathogen responsible for the infections from the heater-cooler devices is a nontuberculous mycobacterium (NTM) called M. chimaera, which is a bacterium that grows slowly and can be present in the body for months and years before it flares up and can be detected. While there is not a blood test that can tell if a person has been exposed to the bacteria, there is a laboratory culture that can be taken. There is also evidence that another NTM called M. abscessus may be present in the devices, and can spread via the exhaust system, which aerosolizes the infection.
Given how slowly the bacteria grow, it can take months or even years before a victim exhibits symptoms. It can also take a long time before the bacteria show up in a culture. Because most of the symptoms of NTM are similar to the flu, it is possible for doctors to fail to diagnose the infection at all.
Some of the symptoms that could mean a person has an infection include:
- Unexplained fever
- Night sweats
- Muscle aches
- Weight loss
While the infection is serious, and in some cases has led to death, it is also rare. The CDC estimates that the risk of infection for those who have undergone cardiothoracic surgery using a contaminated heater-cooler device is less than one percent. The CDC has published this video with information about the heater-cooler device infections.
Warning Letters Sent To Patients About The Risk Of Infection
The CDC sent warning letters to hospitals about the increased risk of infection with the Stöckert 3T heater-cooler device advising them to alert patients who underwent surgeries using the device that they could be affected. The Mayo Clinic sent notifications to 17,000 patients, warning them of their potentially increased risk of infection. The letter directs patients to see their doctor if they begin to experience symptoms of an infection. The FDA reported that 16 hospitals in 10 states have reported patients who have developed infections following open-heart surgery where the contaminated heater-cooler units were used, but they did not name the hospitals or the states where the hospitals were located.
While the Sorin/ Stökert 3T heater-cooler device has been the subject of publicity about the issue of increased infection risk, there are other brands of heater-cooler devices used in cardiothoracic surgery such as the following:
- Maquet HCU 20 (HCU 30 and HCU 40)
- Cincinnati Sub-Zero 33W
We fight to recover compensation for serious injuries in regard to medical expenses, pain and suffering, lost income, loss of enjoyment of life, and loss of consortium for spouses of the injured. As former malpractice defense lawyers, we can anticipate what kinds of arguments the “other side” will make. You can rely on our team to fight for justice for you and your loved ones, and to hold the responsible parties accountable for your injuries and illness.