During complicated cardiopulmonary surgeries, hospitals use the Stӧckert 3T Blood Heater-Cooler to regulate patients’ blood temperature outside the body. But contaminated water in the machine poses serious risks of infection that might not be detected for years.
For people with heart and lung problems, invasive surgery may be the only answer. Those patients entrust their care to the doctors and nurses in the operating room, as well as the equipment the surgical team uses.
No patient anticipates that the equipment is defective, or that the manufacturer’s negligence would expose them to the greatest harm.
That’s what makes the dangers associated with the Stӧckert 3T Blood Heater-Cooler System so shocking.
What Is the Stӧckert 3T?
Manufactured by LivaNova PLC, the Stӧckert 3T warms and cools a patient’s blood as it is circulated outside the body during invasive cardiopulmonary surgeries.
The water is contained in a tank and runs through closed circuits, never coming into direct contact with the blood.
More than 250,000 bypass procedures are performed in the U.S. each year. It is estimated that 60% of those procedures involve the use of a Stӧckert 3T device, which was first introduced to the U.S. market in 2006.
What Makes the Stӧckert 3T Dangerous?
Although enclosed, there is the potential for contaminated water in the 3T’s tank to enter other parts of the device, multiply there, and aerosolize – turning liquid into a fine spray or mist – and transmit bacteria through the device’s exhaust vent fan into the operating room. The offending bacteria is a nontuberculous mycobacterium or NTM, such as Mycobacterium chimaera (M. chimaera). This bacteria moves through the air and enters the patient’s open chest cavity during surgery.
An April 2016 study showed a connection between several cardiothoracic patients infected with M. chimaera, the Stӧckert 3T machines used during the patients’ procedures, and environmental samples from the manufacturer’s facility in Germany. The U.S. Food & Drug Administration (FDA) and the Centers for Disease Control (CDC) have stated that the 3T devices were contaminated with M. Chimaera during production, and that failure by the hospitals to properly disinfect and maintain the units, contributed to the proliferation of the bacteria and the risk to patients’ during surgery.
The procedures that place patients at risk include:
- Coronary artery bypass graft (CABG) surgeries
- Valve surgeries
- Thoracic surgeries such as a transcatheter aortic valve (TAVR) or transcatheter aortic valve implantation (TAVI)
The CDC estimates that more than a half-million patients are at risk of infection, and patients who received prosthetic or artificial valve implants face an even higher risk.
Infection Signs, Symptoms, and Treatment
M. Chimaera is common in soil and water, and though slow to grow in humans, it may cause serious illness or death. M. chimaera infections are difficult to detect because infected patients may not develop symptoms or signs of infection for months to years after initial exposure and the symptoms are often general and nonspecific. Because of the delay, the infection may become difficult to treat.
- Night sweats
- Persistent or unexplained fever
- Muscle aches and joint pain
- Unexplained weight loss
- Difficulty breathing
- Persistent cough or a cough with blood
- Abdominal pain
- Nausea or vomiting
- Infection at the surgical site
Infected patients may also suffer from endocarditis, abscesses, bacteremia, hepatitis, renal insufficiency, splenomegaly, pancytopenia, and osteomyelitis.
M. chimaera can be treated with antibiotics, but patients may require prolonged treatment. Some heart valve patients who develop infections after cardiac surgery may require additional surgery. If untreated, an M. chimaera infection could be potentially fatal, and several patients around the world have died as a result.
What Can You Do If You or a Loved One Is at Risk?
Certain Stӧckert 3T’s were recalled in June 2015, and since then, the FDA and CDC have issued warnings and exerted pressure on U.S. hospitals to notify patients who underwent procedures using the device of the risk.
The following hospitals have issued letters to their patients thus far:
- WellSpan York Hospital
- Penn State Hershey Hospital
- Penn Presbyterian Medical Center
- University of Iowa Hospital
- Mercy Medical Center in Iowa
- Spectrum Health Medical Center
- McLaren Hospital
- Franciscan Health
- Community Heart and Vascular Hospital
- Mayo Clinic
You may have been exposed to M. Chimaera if:
- You had cardiopulmonary surgery;
- You received a letter from the hospital where your surgery was performed informing you that the 3T device was used during your surgery; and
- You subsequently experienced the symptoms described above.
Subsequent testing would need to confirm an NTM infection.
To recover damages for your pain, suffering, lost wages, and other harm, the law gives you only a limited amount of time to pursue your rights.
The attorneys in Sommers Schwartz’s Complex Litigation Group are currently interviewing surgical patients across the U.S. who were placed at risk of infection by contaminated Stӧckert 3T devices.
Please contact us today for a free consultation!