Heater-Cooler Lawsuit Alleges Wrongful Death Due to M. Chimaera Infection

Published on November 7, 2016 by Sandy Liebhard

The manufacturer of a Heater-Cooler device used during cardiothoracic surgery has been hit with a lawsuit following the death of an Iowa man from a fatal M. Chimaera infection. The complaint, which is currently pending in the U.S. District Court, Southern District of Iowa, claims that the Sorin 3T Heater-Cooler system was the sources of the deadly bacteria.

M. chimaera is a form of nontuberculous mycobacterium (NTM). According to the August 22^nd filing, Ronald Prescott was diagnosed with the slow-growing infection in September 2014. The diagnosis followed a 2012 heart valve replacement, at which time the 3T Heater-Cooler was used to regulate the decedent’s blood temperature.

“The 3T System regulates blood temperature by circulating water through tubes into a heat exchanger where blood is pumped into separate chambers during surgery,” according to the complaint. “The water tanks and other areas where water pass through aerosolize a vapor containing NTM, which exits out of the device and is pushed into the ambient air of the operating room through the System’s exhaust fan. If placed in the operating room, the contaminated vapor from the System directly enters the sterile surgical field and the patient’s open body.”

“Hospitals in at least 15 U.S. states have reported patient infections and/or device contamination with NTM,” the lawsuit continued. “Many hospitals have now either discontinued using the 3T System or…have moved the System into a separate room to prevent contaminated aerosols from reaching the surgical field.”

FDA Heater-Cooler Warnings

The U.S. Food & Drug Administration (FDA) first warned about the potential for Heater-Cooler devices to spread NTM infections in October 2015.  Then in June, the agency announced that it was specifically investigating the 3T Heater-Cooler system in connection with illnesses reported in the U.S.  A third alert released last month  confirmed  that 3T Heater-Coolers manufactured prior September 2014 had been directly linked to the U.S. infections.

According to an alert issued by the U.S. Centers for Disease Control and Prevention, signs of an NMT infection can take months to appear. Cardiac patients exposed to the bacteria have presented with a range of symptoms, including endocarditis, surgical site infection, or abscess and bacteremia. Other clinical manifestations have included hepatitis, renal insufficiency, splenomegaly, pancytopenia, and osteomyelitis. Physicians should consider consulting with an infectious disease specialist if a patient develops symptoms of an infection following open cardiac surgery.