Have you or a loved one suffered a serious infection after an open-heart surgery procedure? If your medical care provider used a Stockert 3T heating-cooling system during your surgery, it may have been the cause of your infection.
The Federal Drug Administration (FDA) and the Centers for Disease Control (CDC) have each issued warnings regarding the Stockert 3T heating-cooling system, manufactured by LivaNova PLC, used during open-heart surgery. The device has been shown to cause nontuberculous mycobacteria (NTM), specifically mycobacterium chimaera, due to the presence of this micro organism in the water. The infection is potentially fatal to patients who have been exposed to it.
What Is a NTM Infection?
M. chimaera typically grows in water and soil, and usually will not affect an otherwise healthy person. The symptoms of infection can take months or even years to appear. Infected patients will feel anything from a fever, muscle aches, weight loss, fatigue or night sweats. An infection by the m. chimaera disease occurs when particles float through the air and land in the open wound of a patient. If you do experience any of these symptoms after recently having open-heart surgery, seek medical attention immediately.
The rate of infection is estimated to be anywhere from 1 of every 100 to 1 of every 1,000 patients. Given that the number of open heart surgeries using the heating-cooling machine hovers around 250,000 per year, this means that anywhere from 250 to 2,500 patients have potentially become infected, many of whom may not even know yet due to the exceptionally long incubation period. The survival rate for NTM infection hovers around 50 percent.
Treatment for m. chimaera is nearly non-existent. A variety of methods have been attempted, but recent studies have shown that antimicrobial and antibiotic treatments are largely ineffective against the m. chimaera strain. Even though the CDC notes that there is only a one percent chance of developing an infection, considering our previous math still leaves far too high a number of patients potentially acquiring the disease.
What Are Heater-Cooler Devices?
Roughly 60 percent of open-heart surgeries require a heater-cooler device to be used, amounting to about 250,000 procedures per year. During the surgery, your heart will likely have to be temporarily stopped – otherwise known as cardioplegia – in order for the surgeon to perform the procedure properly. The heater-cooler device regulates body temperature, assists with the flow of blood and oxygen, and moves the blood away from the heart. Essentially, it assumes all the duties of your vital organ function. The water in these machines does not actually come in direct contact with the patient. The problem with the machine is not in its operation, but in its manufacturing.
The water in this particular heating-cooling system flows through three separate tanks, which is done because the system controls oxygenators and blankets as well. The m. chimaera disease actually becomes airborne, as the water can turn into a gas, and infects patients through their open wound.
The Stockert 3T heating-cooling system is being isolated as a direct cause of NTM as a side effect in open heart surgeries. Thousands of open-heart surgery patients across two Pennsylvania hospitals had to be warned about the potential for the disease after it was confirmed that the system caused the death of five patients.
What Is Open-Heart Surgery?
Open-heart surgery is any procedure in which the surgeon makes a large incision to open up the rib cage in order to get to the heart. It is needed to perform a coronary artery bypass graft (CABG), which is necessary to correct coronary heart disease. It can also be done to repair or replace heart valves, damaged or abnormal areas of the heart, implant medical devices or do a complete transplant.
The procedure itself will usually take about 4-6 hours, and the patient is given general anesthesia. An approximately eight-inch long incision is made, the breastbone is cut through to expose the heart, and the surgeon will do whatever is needed; no two open-heart surgeries are exactly alike. As with any major procedure, there are some risks involved.
Survival statistics for heart surgery are incredibly difficult to ascertain, because as previously mentioned, every surgery is different. Each patient has a unique set of risk factors, including age, health history, prior surgeries, overall heart function, and a host of other information of which your doctor and surgeon will need to be aware. Then a calculation can be made determining how long and well you will be able to live after the operation, along with the likelihood of complication.
The most common risks associated with the surgery that patients experience include: wound infection, irregular heartbeat, memory loss, blood clot, heart attack or kidney failure. Some of these are more common than others, but your doctor can be prepared and therefore treat all of these side effects, hopefully without any further damage to your health. The infection caused by a heater-cooler device is much more serious.
In typical Missouri medical malpractice cases, the patient can sue the doctor or the hospital as a whole if they feel that either one acted negligently in diagnosing or treating the illness. In the case of a lawsuit involving a heater-cooler, it would be the manufacturer who comes under trial. Air filters in place on the machine are not adequate enough to efficiently clean the bacteria and prevent it from becoming airborne.
Open-heart surgery is an expensive procedure which requires much time to be missed from work and creates high medical bills. Becoming infected with NTM will only make these things much worse, and could have permanent effects on your life, such as hearing or vision loss. If the manufacturer fails to properly warn the doctor or the patient about the potential side effects, then they should be held responsible for their negligence.
Medical Malpractice Statute of Limitations
In Missouri, the statute of limitations to file a medical malpractice claim is two years from the date the personal injury first occurred. This means that you may not have much time to put a lawsuit together given how long symptoms of NTM take to show themselves. It is possible to have the statute extended due to these circumstances by claiming that you could not have possibly known you were infected the day the disease was theoretically acquired.
A couple more exceptions apply; if the patient is less than 18 years old, then they have until they are 20 to file a malpractice claim, regardless of how many years removed they are from that age. Also, if the claim is being made because proper warning of a potential risk was not given, then the time starts from the date the injury was discovered, rather than when it first occurred. This will give more time to file a claim.