June 2, 2016 — The FDA is warning about the risk of infections that may not cause symptoms for months or years after patients undergo open-heart surgery involving Stӧckert 3T heater-cooler machines.
In a Safety Communication, the FDA said a recent study in Europe discovered that samples of bacteria from patients with infections matched bacteria found in the heater-cooler.
In August 2014, that same bacteria was found in the water supply at a Sorin facility in Germany where the 3T machine is manufactured. The problem has persisted despite new cleaning and disinfection efforts.
The bacteria is known as Mycobacterium chimaera, and it is a type of Non-tuberculosis Mycobacterium (NTM).
The FDA said infections from heater-cooler devices are rare, but they have received at least 32 reports in the United States — with 25 reports last year alone. According to the agency:
“[Infections] are difficult to detect because patients infected with M. chimaera may not develop symptoms and signs of infection for months to years after initial exposure.”
Heater-cooler machines pump temperature-controlled water through circuits to heat or cool patients undergoing cardiothoracic surgery (open-heart and bypass surgery).
Water in the system does not directly contact the patient. However, bacteria in the water can aerosolize through the machine’s exhaust vent and land on the patient.
The FDA asks patients who have had heart surgery to remain vigilant for symptoms of an NTM infection, which may include fever, pain, redness or pus at the surgical site, weight-loss, nausea, vomiting, fatigue, trouble breathing, and more.
Do I have a Heater-Cooler Infection Lawsuit?
The Schmidt Firm, PLLC is currently accepting heater-cooler induced injury cases in all 50 states. If you or somebody you know has been diagnosed with an NTM infection, you should contact our lawyers immediately for a free case consultation. Please use the form below to contact our Defective Medical Device Litigation Group or call toll free 24 hours a day at (866) 920-0753.
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