Risk of Infection Associated with Sorin’s Stockert 3T Heater-Cooler System
Updated News: See our filed complaint.
The Stockert 3T heater-cooler system is a medical device that is used to warm or cool a patient during certain surgeries. Unfortunately, use of this device during open-chest surgery has been linked to infection from a rare bacterium called Mycobacterium chimaera, or M. chimaera. An M. chimaera infection is life-threatening; if you or a loved one were exposed to M. chimaera during surgery, and are experiencing symptoms, you should seek medical attention immediately.
The Stockert 3T devices were manufactured at a facility operated by Sorin in Munich, Germany. In October 2015, the Food and Drug Administration (FDA) issued a Safety Communication stating that it had received thirty-two reports of patient infections associated with heater-cooler devices. Less than a year later, in June 2016, the FDA issued a related Safety Communication, citing strong evidence that the Stockert 3T device was connected to the recent outbreak of M. chimaera infections in patients who had undergone open-chest surgery. The FDA’s June 2016 Safety Communication also made a stunning revelation, stating, “Testing conducted by the manufacturer [Sorin] in August 2014 found M. chimaera contamination on the production line and water supply at the 3T manufacturing facility. Units from this facility can be found worldwide.”
On October 13, 2016, the Centers for Disease Control and Prevention (CDC) issued a Health Advisory to hospitals. This Health Advisory announced that the CDC, in collaboration with National Jewish Health, had completed a whole-genome sequencing analysis, and the results of their analysis suggested that the M. chimaera that had infected patients in the United States came from the same source. The CDC further stated that this single-source contamination was consistent with similar studies conducted in Europe, which matched the M. chimaera from patients to the same bacteria found at the production site in Germany.
Importantly, the Health Advisory issued by the CDC on October 13, 2016 also advised hospitals to alert patients who may be at risk of exposure to M. chimaera from an open-chest procedure. On the same day, the FDA issued an update to it’s earlier Safety Communication. This updated Safety Communication again warned hospitals about the risks of using the Stockert 3T device.
The M. chimaera bacteria is slow growing, and symptoms of an M. chimaera infection can take months or even years to appear. When symptoms do appear, they are vague, which can make an M. chimaera infection difficult to diagnose. However, persons who have been exposed to the M. chimaera bacteria during surgery should be mindful of the symptoms, which can include: fatigue, unexplained or persistent fever, redness, night sweats, heat or pus around the surgical site, muscle aches, or unexplained weight loss. If you have undergone an open-chest surgery that used the Stockert 3T device, and you are experiencing any of these symptoms, you should inform your health care provider as soon as possible.
The Kaiser Permanente Health System used the Stockert 3T heater-cooler devices while these devices were contaminated with the M. chimaera bacteria. The number of patients who may have been exposed to the M. Chimaera bacteria after open-chest surgery at a Kaiser Permanente facility is not known at this time, but several cases have already been reported. Kaiser Permanente has now sent letters warning some of its patients that they may have been exposed to the bacteria. Unfortunately, many of these warning letters came several months after the CDC and FDA advised hospitals to warn patients about possible exposure. When symptoms of an M. chimaera infection begin to show themselves, time is of the essence. An infection can quickly become life-threatening if not treated properly. Kaiser Permanente did not act swiftly to warn its patients or their healthcare providers that they may have been exposed to the deadly bacteria. This delay cost precious time for some patients that could have been used to treat the infection. In at least one reported case, Kaiser Permanente’s warning letter came just days before the patient died from the infection.