The device at issue, called the Stockert 3T, is made by the English medical device company LivaNova and is manufactured in Germany. The device is supposed to help control a patient’s body temperature during open heart surgeries. However, researchers in Switzerland noticed that a cluster of patients infected with M. chimaera had all undergone surgery where a Stockert 3T heater cooler device was used. Based on this information, researchers in the US and Germany compared samples of the bacteria from infected patients to swabs from the Stockert 3T devices used in their surgeries. Based on genome testing, the bacteria strain found in each sample was determined to be nearly identical. This lead the CDC and FDA to the conclusion that the Stockert 3T heater-cooler device was the source of the contamination. German researchers have gone a step further and sourced the contamination back to swabs taken from the German manufacturing plant.
While the FDA has not issued a recall, it has blocked imports of the device from Germany and has issued warnings to patients who may have been affected by the device as well as safety guidelines to hospitals where it is still in use.
The scope of the potential affected patient population is also troubling. It is believed that over 250,000 cardiopulmonary bypass surgeries are performed in the United States each year and the Stockert 3T heater-cooler is used in approximately 60% of those surgeries. Therefore, while the number of patients known to be infected with M. chimaera is relatively small at this point, the potential for infections is staggering. In addition, a patient who is infected with the bacteria may not exhibit symptoms of infection for months to years after their open-heart surgery, and therefore may not link the infection to their surgery, further compounding the problem of source identification.
The FDA suggests patients who have had open heart surgery should seek medical care if they are experiencing symptoms associated with infections, such as night sweats, muscle aches, weight loss, fatigue, or unexplained fever. These symptoms may not present for months to years after surgery, and may indicate that the M. chimaera bacteria is growing deep within the tissue of the patient’s heart which can lead to further surgeries and in some cases, death.
If you or a loved one has suffered a bacterial infection following open heart surgery, please contact the Farr Law Firm for a free and confidential consultation.