Heater-Cooler Infections

Dozens of Heater-Cooler infections, specifically a form of Nontuberculous Mycobacteria (NTM) infection called M. chimaera, have been linked to the use of>Stӧckert 3T Heater-Coolers. These types of devices are used to warm or cool patients during cardiothoracic surgery and other medical procedures.

Legal Help for Those Harmed Due to Heater-Cooler Infections

Bernstein Liebhard LLP is providing free legal reviews to individuals who suffered damages related to a Heater-Cooler infection. If you or a loved one were diagnosed with a Nontuberculous Mycobacteria infection following cardiothoracic surgery or another medical procedure that involved the use of a Heater-Cooler device, please call (888) 994-5118 to learn more about your legal options.

Nontuberculous Mycobacteria Infections Linked to Heater-Cooler Devices

In October 2015, the U.S. Food & Drug Administration (FDA) warned that Heater-Cooler devices had been implicated in a number of Nontuberculous Mycobacteria infections that had occurred in patients undergoing cardiothoracic surgery in the U.S. and abroad.  250,000 heart bypass procedures – about 60 percent of the total performed in the U.S. every year – rely on the use of Heater-Coolers like the Stӧckert 3T. These units aid in keeping a patient’s circulating blood and organs at a specific temperature during open-heart surgery.

Heater-Cooler devices allow temperature-controlled water from a tank to be delivered to heat exchangers or warming/cooling blankets via a closed circuit. Although the water never comes into direct contact with the patient, contaminated water can potentially enter other parts of the device. Contaminated water can also become aerosolized, which may result in the transmission of bacteria through the air via the Heater-Cooler’s exhaust vent.

In June 2016, FDA announced that one particular Heater-Cooler, the Stӧckert 3T, had been implicated in a number of M. chimaera infections overseas. In October, the agency  confirmed that the same device was also linked to similar Heater-Cooler infections in the U.S.  The agency noted that  Stӧckert 3T Heater-Coolers may have been contaminated during manufacturing, as tests conducted in 2014 at the German facility were they were made found M. chimaera on the production line and in the water supply.

What Should Patients Do?

M. chimaera is a species of Nontuberculous Mycobacterium commonly found in soil and water. The bacterium rarely causes illness in humans, though people undergoing invasive procedures and who have weakened immune systems are most at risk. According to the U.S. Centers for Disease Control (CDC), at lest 28 cases of M. chimaera infections linked to Heater-Cooler devices have been identified at hospitals in Iowa, Michigan and Pennsylvania. Cases have also been reported in Europe. Some patients have died, though it is unclear whether the infection was a direct cause of death.

Because NTM grows slowly, it can take months or years for a Heater-Cooler infection to become apparent. The C DC has advised doctors to be aware of the risk and suspect NTM infections among patients who have signs of infection and a history of open-chest cardiac surgery.

Patients who underwent open-heart surgery before 2014 should also be aware of the signs and symptoms of infection, including:

  • Night sweats
  • Muscle aches
  • Weight loss
  • Fatigue
  • Pus around a surgical incision
  • Unexplained fever

The CDC also noted that open-heart surgery patients who have had valves or prosthetic products implanted are more likely to develop these infections.

Heater-Cooler Lawsuit Reviews

A number of lawsuits have already been filed against the manufacturer of Stӧckert 3T Heater-Coolers in relation to the NTM outbreak. If you are interested in pursuing a similar legal claim for a Heater-Cooler infection, please call (888) 994-5118 to arrange for your free case review.

  1. FDA (2016) “Heater-Cooler Device” http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/CardiovascularDevices/Heater-CoolerDevices/default.htm
  2. CDC (2016) “CDC Advises Hospitals to Alert Patients at Risk from Contaminated Heater-Cooler Devices Used during Cardiac Surgery” https://emergency.cdc.gov/han/han00397.asp
  3. CBS News (2016) “Contaminated heart surgery devices may pose infection risk to thousands” http://www.cbsnews.com/news/contaminated-heart-surgery-devices-infection-risk/
Last Modified: October 26, 2016

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