Cardiac Patients File Lawsuits over Infections Linked to Stockert 3T SystemMar 9, 2017
When patients undergo cardiopulmonary operations, a patient warming-cooling system is often used to maintain the patient's blood and organs at a specific temperature to reduce the risk of complications.
One such heating-cooling system, the Stöckert 3T system may put the patient at risk for infection caused by Mycobacterium chimaera, a bacteria that can grow in the device's water tanks and be released into the operating room through the system's exhaust vent.
Stöckert 3T Heater-Cooler System
The Stöckert 3T heater-cooler system is used in the operating room to cool and re-warm a patient's blood during surgery. The Stöckert 3T uses a closed-water circuit with three water tanks that use heating or cooling blankets to keep blood at the optimal temperature for patients undergoing heart procedures. But Mycobacterium chimaera bacteria in the device's water tanks can be released into the operating room and contaminate the surgical site.
M. chimaera, a nontuberculous mycobacterium (NTM), is a slow grower. There can be a delay as long as several years between the time a patient is exposed to the bacteria and when an infection occurs. M. chimaera may cause serious illness or death, but the infection can be difficult to detect because it can take so long for the infection to develop after exposure.
NTM organisms may cause infections in patients with compromised immune systems, underlying lung disease, diabetes, those undergoing chemotherapy or certain invasive healthcare procedures, or receiving organ transplants.
The Stöckert 3T was approved by the U.S. Food and Drug Administration (FDA) in 2006. The system was originally developed by the Sorin Group, which merged with another European medical device maker in 2015, to become what is now LivaNova.
The Stöckert 3T heater-cooler system is associated with nontuberculous mycobacteria (NTM) infection, which can cause serious illness or even death.
Patients who have undergone cardiac surgery should be aware of possible signs and symptoms of NTM infection:
- redness, heat, or pus at the surgical site
- muscle pain
- joint pain
- night sweats
- weight loss
- abdominal pain
Cardiac patients who experience any of these symptoms should speak with doctor about the possibility of an NTM infection. Special cultures may be needed to help diagnose the infection.
Diagnosing an NTM infection can be challenging, because the infection has a long incubation period before symptoms begin to emerge. The infection is difficult to successfully treat. In some cases, a patient needs a second surgery to remove an implant that may have become contaminated with M. chimaera during surgery.
Link Between Stöckert 3T and NTM Infections
Nontuberculous mycobacteria exist in the environment in water and soil and do not normally pose a risk to human health. But research has shown NTM organisms in the Stöckert 3T water tanks can be released into the operating room through the device's exhaust vent. The NTM bacteria can enter the patient's chest cavity and any can contaminate an implant such as a new valve or grafts, possibly causing an NTM infection. Thirty-two cases cases of M. chimaera were reported to the FDA between 2010 and 2015, all involving patients who had undergone surgeries where the Stöckert 3T system was used. Nearly half those patients died.
Research studies have identified NTM infections in cardiac patients
Lawsuits Against LivaNova for NTM Infections
Lawsuits filed against LivaNova in 2016 include a product liability lawsuit brought by a patients who allegedly contracted an NTM infection during open-heart surgery where the Stöckert 3T system was used. A wrongful death complaint was filed in the death of a 62-year-old patient who died from an NTM infection nearly a year after undergoing surgery with a Stöckert 3T heater-cooler system at a Pennsylvania hospital. A South Carolina man filed a product liability lawsuit against LivaNova in July 2016. He had an aortic valve replacement and cardiac bypass grafting procedure in 2014, during which the Stöckert 3T system was used. Eventually, he developed a fever, weakness and pneumonia that were attributed to NTM.
FDA Warnings about the Stöckert 3T
On June 1, 2016, the FDA issued a safety communication about M. chimaera infections associated with the use of the Stöckert 3T heater-cooler. Testing conducted by the manufacturer in August 2014 found M. chimaera contamination on the production line and water supply at the manufacturing facility. The manufacturer added cleaning and disinfection procedures to the production line in September 2014. Samples taken at the by the German Regulatory Authorities in July 2015 did not show M. chimaera, potentially indicating the contamination at the manufacturing facility had been resolved. Despite these measures, some 3T devices manufactured after September 2014 have tested positive for M. chimaera. It has not been confirmed whether these devices were contaminated at the manufacturing facility or became contaminated at the user facility. To date, the FDA is not aware of M. chimaera patient infections associated with 3T devices that were manufactured after September 2014.
The FDA recommends facilities using Stöckert 3T heater-cooler units take measures to reduce the risk to patients.
- Do not use tap water to rinse, fill, refill or top-off water tanks. This may introduce NTM organisms. Use only sterile water or water that has been passed through a filter of less than or equal to 0.22 microns.
- When making ice for patient cooling during surgical procedures use only sterile water or water that has been passed through a filter of less than or equal to 0.22 microns.
- Direct the heater-cooler's vent exhaust away from the surgical field to reduce the risk of aerosolizing heater-cooler tank water into the sterile field and exposing the patient.
- Establish regular cleaning, disinfection and maintenance schedules for heater-cooler devices according to the manufacturers' instructions to minimize the risk of bacterial growth and subsequent patient infection.
Legal Help for Those Harmed by the Stöckert 3T Heater-Cooler
If you or someone you know has developed an NTM infection after surgery where the Stöckert 3T heater-cooler system was used, contact the attorneys at Parker Waichman LLP for a free, no obligation case evaluation. To reach the firm, fill out the contact form or call 1-800-YOURLAWYER (1-800-968-7529).