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FDA Warns of Infection Risks with Sorin 3T Heater-Coolers

Healthcare professionals commonly use the Sorin 3T Heater-Cooler System when providing cardiothoracic and cardiopulmonary patients with heat exchangers and warming/cooling blankets. However, recent warnings by the Food and Drug Administration (FDA) highlight the significant risk of infection in using this device, which could lead to substantial injuries for these vulnerable patients.

Uses of Sorin 3T Heater-Coolers

Heater-cooler devices help cool or warm patients recovering from various medical procedures, including cardiothoracic surgeries. These devices include a water tank that delivers temperature-controlled water to external heat exchangers or warming/cooling blankets. The water travels through closed circuits and never directly touches the patient. However, it may penetrate other parts of the exchanger or blanket, where it is converted into a fine mist and released through an exhaust vent. If water provided by the heater-cooler contains bacteria, the exhaust releases these dangerous germs into the air and the patient’s environment.

FDA warnings

The FDA first issued recommendations about these heater-coolers in 2015, informing healthcare professionals about the potential risk of infection and suggesting measures to minimize patient injury. Since that time, ongoing studies have reportedly demonstrated a connection between a bacterium called M. chimaera and the Sorin 3T heater-cooler units. According to the FDA, M. chimaera is a type of nontuberculous mycobacterium (NTM). These bacteria can lead to serious illness or death if not detected and treated in a timely manner. Unfortunately, the symptoms may not develop for months, or even years after contraction, which can lead to a delayed diagnosis.

In 2014, the Sorin 3T manufacturer discovered a contamination of M. chimaera on the product line and in the water produced by the heater-cooler. Though the company added cleaning and disinfection instructions to the product literature, numerous machines were already in use by medical facilities around the world. The FDA has reportedly received more than 60 reports globally in regard to these devices and incidents of infection. In addition, more than 100 reports indicate that contamination was confirmed within the heater-cooler unit.

Holding the manufacturer responsible

The experienced Atlanta and Savannah lawyers of Harris Lowry Manton LLP are currently investigating cases from surgery patients who developed a bacterial infection after receiving treatment from a Sorin 3T Heater-Cooler. Our knowledgeable Georgia product liability lawyers have the resources and skill to thoroughly review your case and bring a comprehensive claim that holds all responsible parties accountable and adequately compensates your physical, mental, and financial injuries. For more information, please call us at 407.998.8847 in Atlanta, at 912.417.3774 in Savannah, or fill out our contact form.




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