As many as a half million open heart surgery patients since 2006 could develop a potentially deadly illness due to the Stockert 3T Heater-Cooler device. The Stockert 3T uses water to maintain a patient’s body temperature during surgery. The CDC reports that the device provides an ideal breeding environment for a potentially deadly bacterium.
Known as mycobacterium chimaera or “non-tuberbulous mycobacterium” (NTM), this bacterium is fairly common and usually innocuous. For patients with compromised immune systems who have undergone invasive surgery, however, it can be life-threatening. Some thirty cases were reported in the U.S. in 2016, and several more were reported in Europe. These numbers may only be only the tip of the iceberg, because NTM infections can have an incubation period of several months or even much longer. The bacterium infection may not even be identified for years. Symptoms, unfortunately, are common to many illnesses: muscle pain, chronic fatigue, fever. In addition, NTM can be resistant to most antibiotics.
Fatal Infection in half the cases
Some 250,000 open heart surgeries performed in the U.S. yearly employ heater-cooler units to regulate patient body temperatures. About 60% of these surgeries employ the Stockert 3T units.
FDA Safety Communication
The FDA issued a safety communication Oct. 15, 2015 regarding nontuberculous mycobacterium infections associated with the Stockert 3T Heater-Cooler devices.
FDA Statement on Contamination
LivaNova, a medical device manufacturer in Germany, makes the Stockert 3T. Recent investigations show these units were contaminated at the factory. The relevant manufacturing facilities were inspected in 2015, at which time they revealed numerous violations of standard safety protocols. In summer 2016, an FDA statement reported that nearly every Stockert 3T unit made before September of 2014 could be contaminated with NTM bacteria. Consequently, as many 500,000 people who have undergone open heart surgery since the device was introduced to the U.S. in 2006, could either suffer from, or be at risk of, developing an NTM infection. Most of these people are unaware of their exposure to the defective Stockert 3T heater cooler, though some have been notified.
Surgical Heater-Cooler Infections can be Fatal
The FDA is now issuing statements to health care facilities around the U.S., advising medical personnel to stop using the Stockert model and to use new accessories, such as tubing and connectors. This alternative should avoid recontamination of any replacement equipment. The FDA also strongly recommends that only water that has been carefully filtered be used for these devices.