A growing number of individuals nationwide are filing nontuberculous mycobacteria (NTM) lawsuits over problems with 3T Heater-Cooler Systems found in operating rooms nationwide, after it was discovered that certain devices may have become contaminated and caused individuals to develop symptoms of the severe infection months or even years after surgery.
In a complaint (PDF) filed last week in the U.S. District Court for the Western District of North Carolina, Van Sidney Blevins, III, indicates that he contracted the infection during a liver transplant operation in June 2015, when one of the contaminated devices was used to control blood temperature during surgery.
The Sorin 3T Heater-Cooler has been commonly found in hospitals throughout the U.S. in recent years, but federal regulators recently warned that certain devices manufactured before September 2014 may have become contaminated, releasing vapor through the exhaust system that may cause nontuberculous mycobacteria (NTM) infections, such as M. Chimaera and M. Abscessus. These bacteria occur naturally in the environment and rarely cause illness. However, when an individual’s organs and chest cavities are directly exposed during surgery, it poses a particularly serious risk.
Blevins indicates that a 3T Heater-Cooler was used during an orthotopic liver transplant in June 2015, before the manufacturer or federal regulators warned about the problems linked to the device. Following the surgery, Blevins began to suffer from fever, abdominal pain and diarrhea. A CT scan indicated that he suffered from an enlarged spleen, abdominal ascites and an intra-abdominal abscess, according to the lawsuit. However, no infection was found after multiple cultures were taken and he was given prophylactic antibiotics.
During the weeks that followed, the infection symptoms persisted and worsened, and by late August Blevins was suffering from a persistent fever, poor wound healing, and the abdominal pain continued. However, it was not until September 2015 that he was diagnosed with Mycombacterium abscessus.
As a result of the surgical nontuberculous mycobacteria (NTM) infection, Blevins has been hospitalized repeatedly and required IV antibiotic treatments, multiple blood transfusions, debridement surgeries and has suffered multiple other health problems, including malnutrition.
“Despite aggressive, ongoing antibiotic treatment for the past 13 months, Sidney Blevins is still infected with NTM and has only recently seen improvements in his overall health,” the lawsuit states.
Surgical Heater-Cooler Infection Problems
The FDA first warned about the surgery infection risk from surgical heater-coolers in October 2015, only a few months after Blevins surgery, reporting that a large number of adverse event reports had been received in connection with the devices.
In June 2016, a panel of experts were convened to evaluated the problems, indicating that at least 34 reports involving bacterial infections following heart surgery involving heater-cooler systems had been received between January 2010 and August 2015.
Last month, the federal regulators issued a safety communication warning about the infection problems with 3T Heater-Coolers, noting that water tanks used by the devices can become contaminated and spread contaminants to other parts of the system, where they can be released into the air.
The U.S. Centers for Disease Control and Prevention (CDC) also issued a Health Alert Network advisory over the potential risk of M. Chimaera infections following heart surgery, indicating that about 60% of the 250,000 heart bypass procedures performed each year in the United States involve the use of affected 3T Heater-Cooler systems.
The FDA is now advising facilities using 3T devices to remove the devices and any accessories from service if they have tested positive for the bacteria, or have been linked to patients who later were identified as infected. The agency also recommends using new accessories, tubing and connectors if using a new heater-cooler device, channeling exhaust from the devices away from patients and into an operating room exhaust vent, and to review the recommendations in the CDC’s health advisory.
Over the coming months, it is expected that additional cases will be filed as nontuberculous mycobacteria (NTM) infection lawyers continue to review claims for individuals and families who may have undergone heart surgery or another procedure where a contaminated 3T Heater-Cooler was used.