Lawsuit Alleges Serious Infection from 3T Heater-Cooler System

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Public Health Watchdog Breaking News
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A South Carolina man has filed a lawsuit over a post-surgical infection he alleges was caused by a heating-cooling device used during his liver transplant surgery.

The man received a liver transplant in June 2015 to treat end stage liver disease. During his surgery, LivaNova’s 3T Heater-Cooler System was used to control the temperature of his body.

The plaintiff alleges use of the heater-cooler led to a dangerous nontuberculous mycobacterium (NTM) infection. Less than ten days after the transplant surgery, he returned to the hospital with fever and abdominal pain. He susbsequently returned to the hospital a number of times complaining of fever and abdominal pain and each time he was discharged with an antibiotic prescription.

Eventually, scans revealed an abscess forming inside his abdomen. Cultures from his abdomen revealed Mycobacterium abscessus (a nontuberculous mycobacterium). According to legal documents, although the man received aggressive antibiotic treatment for more than 13 months, he continues to suffer from the NTM bacterial infection.

Parker Waichman notes that surgical warming and cooling devices like the 3T and the Bair Hugger have been alleged to introduce bacteria into open surgical sites during heart surgeries, joint replacement, and other procedures with an open surgical site.

The plaintiff filed this lawsuit after learning that he and thousands of other patients undergoing major liver, lung, or cardiac surgery have been exposed to these potentially deadly bacteria. While the bacterial infection may be treatable if diagnosed at an early stage, it can become deadly if left to develop.

Surgical Warming and Cooling Systems

LivaNova’s 3T Heater-Cooler is used during surgery to help keep the patient’s blood and organs at the proper temperature. The 3T Heater-Cooler consists of tanks with temperature- controlled water. Surgeons say that keeping the patient’s body temperature at the ideal level during surgery improves outcomes.

The 3T heater-cooler contains tanks that provide temperature-controlled water to external heat exchangers or to warming/cooling blankets through closed circuits. The Food and Drug Administration (FDA) explains that NTM in water can grow in the water tanks of the heater-cooler device. The water in the heater-cooler device does not come into direct contact with the patient, but the 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. Bacteria in the air can enter the body through the open-chest cavity or on a sterile implant.

The 3T’s water tanks are not air tight, so aerosolized NTM “can escape from the inside of the heater-cooler unit and out the vent(s) and into the surgical suite, possibly facilitated by the unit’s fans,” according to the FDA. Water droplets containing NTM bacteria may remain suspended in the air, which may increase the chances of entering an open surgical cavity or contaminating an implant such as a heart valve or joint replacement device.

Patients Exposed to Dangerous Bacteria

Devices like the 3T Heater-Cooler are used in about 250,000 heart surgeries and other procedures each year. Around 60 percent of those devices currently in use have been connected with life-threatening infections. The U.S. Food and Drug Administration (FDA) and the U.S. Centers for Disease Control and Prevention (CDC) have both issued warnings about the infection danger associated with these devices.

In October 2016, the FDA updated an earlier safety communication to provide new information about M. chimaera infections associated with use of the LivaNova (formerly Sorin Group Deutschland GmBH) Stöckert 3T Heater-Cooler System. Samples of the water drained from the 3T devices and air samples collected while the devices were in operation were tested. The results strongly suggest the 3T heater-cooler units are the source of M. chimaera contamination.

To reduce the risk of NTM infection, the FDA advises hospitals to strictly adhere to cleaning and disinfection instructions provided by the 3T manufacturer. Tap water should never be used to fill, rinse, or top off the heater-cooler water tanks. Tap water could introduce NTM organisms into the tank. Only sterile water or water that has been passed through a filter of less than or equal to 0.22 microns should be used in the tank or for making the ice needed for patient cooling during surgical procedures. 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.

Legal Help for Those Suffering 3T Heater-Cooler Infections

If you or someone you know has developed an NTM infection after surgery where LivaNova’s 3T Heater-Cooler was used, please contact the attorneys at Parker Waichman LLP for a free, no obligation case evaluation. To reach the firm, fill out online form or call 1-800-YOURLAWYER (1-800-968-7529).