The machine is the Stӧckert 3T Heater-Cooler made by LivaNova. It pumps water into a special blanket to keep a patient warm or cold.

The water never touches the patient, but it does evaporate and spray into the air through the exhaust vents. If the water is contaminated, bacteria can land on a patient during surgery and cause an infection.

Just watch this video from the CDC:

The FDA now says tests “strongly suggest” the devices had a single source of contamination — likely the manufacturing facility in Germany where the bacteria was found in the water and production line in 2014.

sorin-3t

Sorin 3T Heater-Cooler

That means many of the machines in the United States could be contaminated. Out of 250,000 open-heart surgeries last year, about 60% involved the 3T Heater-Cooler.

The manufacturer enhanced cleaning and disinfection efforts in September 2014, but new machines made since then have tested positive for the bacteria. Imports were banned in January 2016.

Six hospitals in Pennsylvania, Michigan, and Ohio have reported outbreaks. Only 32 cases have been reported to the FDA since 2010, but it is likely that many more cases were never reported.

The bacteria is slow-growing and it can take years for symptoms to appear. Seek medical attention immediately if you have abnormal fatigue, fever, aches and pains, pus or redness around the incision, night sweats, weight-loss, nausea, and vomiting.

The bacteria causing the outbreaks is called M. chimaera. It is a type of Non-Tuberculosis Mycobacterium (NTM) that is commonly found in soil and water. It resists most antibiotics and the only treatments that work have severe side effects.

Outbreaks have been reported at the following hospitals:

  • Wellspan York Hospital: 1,300 exposed — 12 cases (October 2011 to July 2015)
  • Penn State Hershey Hospital: 2,300 exposed — 5 cases (November 2011 to November 2015)
  • Penn Presbyterian Medical Center: 1,100 exposed — 4 cases (October 2013 to December 2015)
  • University of Iowa: 1,500 exposed — 3 cases (January 2012 to January 2016)
  • Mercy Medical Center in Iowa: 2,600 exposed — 2 cases (July 2012 to July 2016)
  • Spectrum Health Medical Center in Michigan: 4,500 exposed — 2 cases (January 2012 to November 2015)

Source: FDA Safety Communication

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