A woman whose husband was exposed to non-tuberculous mycobacteria during cardiac surgery has filed a lawsuit against LivaNova and Sorin Group alleging the Sorin 3T Heater-Cooler System used during her husband’s surgery ultimately led to his death.
The plaintiff’s husband underwent cardiac bypass surgery in March 2014 at Greenville Health System Hospital (GHS) in South Carolina. A Sorin 3T Heater-Cooler system was used during the procedure. The plaintiff’s lawsuit alleges the heater-cooler exposed her husband to nontuberculous mycobacteria. Nontuberculous mycobacteria (NTM) infections can cause pulmonary disease resembling tuberculosis.
The Sorin 3T Heater-Cooler
The Sorin 3T Heater-Cooler is a medical device used during heart surgeries to keep the patient’s organs and blood at the proper temperature during the procedure. Keeping the patient’s body temperature at the ideal level during surgery improves outcomes. Temperature-controlled water heats exchanger devices in the operating room. Though the water does not directly come into contact with the patient, the Food and Drug Administration (FDA) says, “there is potential for contaminated water to enter other parts of the device and aerosolize,” meaning that the bacteria can be transmitted through the air to the patient.
Patient warming devices like the Sorin 3T Heater-Cooler are used in about 250,000 heart surgery procedures each year. About 60 percent of those devices currently in use have been connected with life-threatening infections, according to Top Class Actions. The Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC) have both issued warnings about the infection danger associated with these devices. Parker Waichman notes that another patient warming system, the Bair Hugger, is also associated with post-operative infections, particularly in patients who have had joint replacement surgery.
Complications Associated with Use of the Sorin 3T Heater-Cooler
GHS announced in June 2014 that around 14 patients had tested positive for a rare infection, known as mycobacterium abcessus. The majority of these patients were exposed to the bacteria during open-heart surgery at the hospital. At the time the announcement was made, three of the infections had resulted in the patient’s death. In July, GHS confirmed 15 actual cases of mycobacterium infections, and a total of four deaths.
Nontuberculous mycobacterium infections can sometimes be successfully treated with a prolonged course of antibiotics and removal of infected tissue. But in some cases, treatment is unsuccessful and patients die because of the infection.
The CDC advises heart surgery patients experiencing the following symptoms to seek medical attention because the symptoms might be linked to a bacterial infection:
- night sweats
- muscle aches
- weight loss
- unexplained fever
After the July announcement, the hospital sent out about 180 letters to patients “on whom specific cardiopulmonary surgical equipment had been used.” The plaintiff’s husband allegedly received one of these letters, according to Top Class Actions.
Health Agency Warnings
The FDA and CDC report that the Sorin 3T heater-cooler devices were allegedly contaminated with the Mycobacterium chimaera during manufacture in Germany. The contamination was discovered in September 2014 at the manufacturing facility for the Sorin 3T machines. Repeat testing in July 2015 showed that the problem had been resolved. Sorin 3T Heater-Coolers manufactured after September 2014 are not linked to the harmful bacteria.
To avoid introducing mycobacteria into the system, the FDA says tap water should never be used to fill, rinse, or top off the Sorin 3T water tanks. In addition, the heater-cooler’s exhaust vent should be directed away from the surgical field to reduce the risk of exposing the patient to bacteria from the exhaust.
In July 2015, the FDA announced a Class II recall of the Sorin 3T System. The FDA announcement noted the “potential colonization of organisms, including Mycobacteria, in Sorin Heater Cooler Devices, if proper disinfection and maintenance is not performed per instructions for use,” another Sorin 3T Cooler-Heater lawsuit states. A Class II recall is the intermediate recall category. Use of the product “may cause temporary or medically reversible adverse health consequences,” but the probability of serious health consequences is remote.
The plaintiff’s lawsuit contains a number of counts against the device manufacturers, including negligence, strict product liability, breach of express warranty, breach of implied warranties, negligent misrepresentation, misrepresentation by omission, violations of the South Carolina Unfair Trade Practices Act, survival, loss of consortium (spousal companionship) and wrongful death. She seeks punitive damages and actual damages including medical bills and expenses, loss of earnings and loss of enjoyment of life.
Legal Help for Those Harmed by the Sorin 3T Heater-Cooler
If you or someone you know has developed an NTM infection after surgery where the Sorin 3T Heater-Cooler was used, please contact the attorneys at Parker Waichman LLP for a free, no obligation case evaluation. To reach us, fill out the firm’s online form or call 1-800-YOURLAWYER (1-800-968-7529).