Sorin FDA Alert

Sorin FDA Alert

The Sorin Stockert 3T heater-cooler device has been the subject of at least 3 FDA alerts, an FDA recall, and a strongly-worded warning letter to device manufacturers after multiple severe bacterial infections were traced to contamination in manufacturing plants which infiltrated devices. Now, at least six patients in the United States have died from infections linked to the Sorin 3T, and many more have suffered serious and painful infections which may affect them for the rest of their lives.

Although the FDA has been vigilant in publishing and updating Sorin Alerts as federal investigations uncover more information about these devices, regulators say that it is possible that additional patients will still suffer Sorin infections, which may present years after initial exposure to the bacteria M. chimaera.  Our medical device attorneys are dedicated to making sure that victims of Sorin 3T infections recover the full compensation to which they are entitled.


What is the Sorin 3T?

The Sorin Stockert 3T heater-cooler device is used during open heart surgery to regulate patients’ blood temperature. This device uses water to adjust the temperature of the blood as it is circulated through a heart-lung machine. While the Sorin 3T nor the water inside of it ever come into direct contact with a patient’s blood, it is possible for bacteria in the device to become airborne when it moves through the exhaust vent.

When patients in Switzerland, Germany, and the United States began to suffer from severe bacterial infections like M. chimaera after open heart surgery, investigators realized that a heater-cooler device was used in each of their procedures. While it may be possible for any heater-cooler device to spread bacteria, M. chimaera was identified at a German plant where the Sorin 3T is manufactured. As a result, the FDA has recalled the Sorin 3T, warned Sorin about safety violations at their factories, and issued multiple Sorin safety alerts.


FDA Alerts and Recalls for the Sorin 3T

Despite multiple FDA alerts and even a recall of the Sorin 3T System, it is still unknown whether this or other heater-cooler devices could be contaminated and pose the risk of serious infections. Additionally, since the FDA states, “infected patients may not develop symptoms or signs of infection for months to years after the initial exposure” to bacteria in heater-coolers, it is highly possible that additional Sorin 3T infections will be diagnosed.

This is a brief recounting of the multiple actions the FDA has taken to mitigate the risk of deadly Sorin 3T infections:

 

  • On July 15, 2015, the FDA announced a recall of the Sorin Stockert 3T, stating that the device had “potential colonization of organisms, including Mycobacteria.”
  • The FDA issued the first warning about heater-cooler infections in October 2015, and has updated this warning numerous times since then as new details are uncovered. At this time, the FDA had received 32 reports of infections linked to heater-cooler devices between January 2010 and August 2015, 25 of which were reported in 2015. The FDA also said, “It is possible that some cases have not been reported to the FDA. It is challenging for a health care facility, health care provider, manufacturer, or patient to recognize that infections, particularly NTM infections, may be associated with the use of or exposure to a particular medical device.”
  • On December 29, 2015, the FDA warned Sorin in a letter that inspections of multiple Sorin facilities uncovered safety violations.
  • On June 1, 2016, the FDA specifically linked the recent infections to the Sorin 3T, and stated that all Sorin 3T devices manufactured before September 2014 may be contaminated. At this time, the FDA instructed all healthcare facilities that had purchased a Sorin 3T heater-cooler to follow the CDC’s guidelines for monitoring patients after surgeries in which this device was employed for any signs of infection. The also announced that later that month the FDA’s Circulatory System Devices Panel would convene to discuss Sorin 3T infection risks and the possibility of future regulation of all heater-cooler devices.
  • In October 2016, the FDA released another Sorin 3T infection update and warning, providing more information on the bacteria behind the infections, Mycobacterium chimaera (M. chimaera). At this time, the regulatory agency also issued stronger guidelines and instructions to help hospitals mitigate the possible risk of deadly Sorin 3T infections. Despite the risk of infection, the FDA stated, “In appropriately selected patients, the benefits of temperature control during open chest cardiothoracic procedures generally outweigh the risk of infection transmission associated with the use of these devices.” Still, medical facilities were encouraged to limit the use of heater-cooler devices only to cases where it is deemed medically necessary and to transition away from Sorin heater-coolers until it is clear the risk of patient infection has been eliminated.

 


Speak with a Sorin 3T Lawyer

If you or your loved one has undergone open heart surgery after 2014, it is highly possible that a Sorin 3T heater-cooler was used during this procedure. Since it may take years for M. chimaera infections from a Sorin device to become symptomatic, it is essential that you remain alert to any health changes and notify your doctors of your possible exposure to this bacteria. If you have already suffered personal injury or the loss of a loved one due to a Sorin 3T infection, you may have grounds for a Sorin lawsuit and we are ready to support you as you demand the compensation you deserve. To speak with a Sorin 3T lawyer at no cost to you, please contact us today.