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Surgical Heater-Cooler Devices Are Causing Deadly Infections

Posted on 12/01/2016Back

WHAT IS A HEATER-COOLER DEVICE?

A heater-cooler device provides temperature controlled water to 3 types of devices:

(1) oxygenator heat exchangers;

(2) heart paralysis heat exchangers; and

(3) warming/cooling blankets.

Here is how it works:

The heater-cooler device has a tank of water. It heats or cools the water as needed, and then pumps that water out into one of the above-mentioned devices. In all three of the above-mentioned devices, the heater-cooler is a “closed system.” Think of a closed system as a circle, where the hot/cold water continues to circulate. Water is brought to the desired temperature in the tank, pumped out to the attached device, and then pumped back into the tank to be reheated or re-cooled. This process repeats itself as needed. The heater-cooler device maintains its own temperature through the use of an exhaust vent which blows hot air out of the machine to cool it down.

WHAT IS GOING WRONG?

Unfortunately, heater-cooler devices manufactured by the German company – LivaNova PLC – have been harming patients across the U.S. The device causing harm is called the “Stöckert 3T.” There are about 2,000 of them in the U.S.

These devices are infecting patients with Mycobacterium chimaera. This bacterial infection grows within the water tank of the heater-cooler, but the exhaust vent is the true problem. Particles of infected water from the tank are blown out of the machine through its exhaust fan into the air (“aerosolized”). This aerosolized Mycobacterium then floats out onto the patient’s open wound or implant infecting the patient. A report from the U.S. Center for Disease Control and Prevention says that not only can Mycobacterium grow in the heater-cooler’s water tank at the hospital, but some water tanks are shipped from the factory with the Mycobacterium already living inside it.

MYCOBACTERIUM CHIMAERA INFECTION

Mycobacterium generally isn’t harmful to healthy people, but it can lead to serious infections for others. If left untreated, these infections can be fatal. For example, in 2014, Mycobacterium infected 15 patients at a hospital in South Carolina. Four of the infected patients died. Although all four of the patients who died had complex medical conditions, authorities admit that the infection may have contributed to their deaths.

RISK FACTORS AND SYMPTOMS

Patients at the highest risk for being harmed from a Mycobacterium infection are those who: have an already weakened immune system, have lung disease, have diabetes, are undergoing chemotherapy, or are receiving an implant or transplant.

Mycobacterium grows slowly. Consequently, it can take months, even over a year, to develop into an infection. Symptoms of Mycobacterium include:

  • Fatigue;
  • Fever;
  • Pain;
  • Redness, heat, or pus at the surgical site;
  • Muscle pain;
  • Joint pain;
  • Night sweats;
  • Weight loss;
  • Abdominal pain;
  • Nausea; and
  • Vomiting

Mycobacterium infection can be treated. For most patients, a combination of antibiotics will do the trick. But for patients who developed a Mycobacterium infection after undergoing heart-valve surgery, a revision heart-valve surgery is necessary. Stöckert 3Ts are used in about 60 percent of all heart surgeries in the U.S. Therefore, if you experience any of the above-named symptoms following heart surgery make it a priority to visit your doctor to rule out a potentially fatal infection.

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