Open-heart surgery patients whose surgical teams employed the Stockert 3t Heater-Cooler device during the procedure are at risk for developing a dangerous, life-threatening infection up to seven years later.
The U.K. Daily Mail describes the infection, caused by a bacterium known as mycobacterium chimaera, as a “blood eating” disease. This bacterium, which is fairly common, has little effect on healthy people. However, those with compromised immune systems and have had open-chest surgery could be at risk – even seven years after exposure.
Currently, Britain’s National Health Service is tracking 47,000 patients who have had surgery over the past four years. The U.K. Medicines and Healthcare Products Regulatory Authority (MHRA) reports that more than 33% of the heater-cooler machines used in hospitals are contaminated with m. chimaera.
In the U.S., m. chimaera contamination has been reported in hospitals in ten states from Washington to North Carolina. There have been nearly 30 fatalities from m. chimaera infections reported over the past decade. Although this contamination usually occurs in the operating room, the FDA reports that tests on the devices from 2014 revealed m. chimaera contamination on the factory production line as well as the water sources at these facilities – indicating that these machines arrive at hospitals already contaminated. Today, contaminated machines have been found in hospitals in five countries across the world.
According to figures from the Centers for Disease Control, as many as 2500 patients undergoing open-chest surgery each year are at risk for contracting an m. chimaera infection.
The Stockert 3t Heater-Cooler Unit employs water in order to maintain a patient’s body temperature. While the water itself does not come into contact with the patient, it evaporates and is vented into the operating room environment. If there is any bacteria in the water, then it is released into the air as well – and if it lands inside a patient’s open incision, the results can be fatal.
Because m. chimaera can have a lengthy incubation period, patients who have had cardio-thoracic surgery are advised to be aware of the symptoms of an m. chimaera infection. These can include:
- difficulty breathing
- chronic fatigue
- persistent cough or cough with blood
- unexplained fever
- redness, heat, or pus at the surgical site
- muscle pain
- joint pain
- night sweats
- weight loss
- abdominal pain
While the Stockert 3t Heater-Cooler has been the culprit in most cases of m. chimaera infections, they are not the only ones. A recent study by health authorities in Denmark found m. chimaera infestation in 86% of the machines that were tested, including units from Maquet.