Devices Linked to Surgical Infection Lead to Stockert 3T Heater-Cooler Lawsuits

December 13 2016 | Blog
  • The FDA and CDC have issued health and safety warnings for any patients that may have been exposed to a certain medical device. This device, the Stockert 3T Heater-Cooler manufactured by LivaNova, is used during surgery to keep the patient’s temperature regulated, but it has lead to multiple lawsuits regarding its tendency to cause bacterial infection in patients.

    Since open heart surgery patients are the most likely to have been exposed to a Stockert 3T Heater-Cooler, they face the greatest risk of infection. Such infections are likely to cause serious illness with a high risk of death.

    The CDC advises that any patients who have recently had cardiac surgery and experience symptoms that include persistent fever, severe aches, unexplained weight loss, chronic fatigue and redness, heat, or pus around a healing surgical incision should seek medical evaluation immediately. They can also seek the help of experienced medical device attorneys who can pursue compensation for serious injuries or deaths resulting from defective medical products like the Stockert 3T Heater-Cooler.

    Why the Stockert 3T Heater-Cooler Has Been Linked to Infections
    The Stockert 3T Heater-Cooler is a medical device originally developed by the Sorin group but that is now owned and manufactured by LivaNova. It is used during surgery in order to help heat or cool the patient’s body as needed, lessening the risk of shock or other complications. This device is extensively used in open heart surgeries and other major, long-duration surgical procedures.

    The way the Stockert 3T Heater-Cooler works is by cycling water through tubes into a heat exchanger or a blanket using closed circuits. This water never comes in direct contact with the patient.

    Nevertheless, the water inside a Stockert 3T Heater-Cooler provides ideal colonization conditions for a strain of nontuberculous mycobacteria (NTM) dubbed M. chimaera. When this bacteria reproduces within the Heater-Cooler exchange system, it can become airborne via the unit’s own venting mechanism.

    Any nearby surgical patients will have open cavities can fall victim to conditions leading to a potentially fatal infection. The website asserts that M. chimaera can cause infections that have a roughly 50 percent mortality rate.

    Some devices may have even become contaminated during manufacture at their German production facility. Stockert 3T Heater-Cooler devices have proven difficult to properly disinfect, maintain and monitor for the presence of bacteria throughout their product life cycle.

    Fatalities and Stockert 3T Heater-Cooler Lawsuits Already Reported
    The FDA has recorded 32 cases of M. chimaera between 2010 and 2015. Around half of these infected have died.

    Worse, many Stockert 3T Heater-Cooler units still remain in service. Even when following FDA Safety Communication guidelines, these units can be difficult to prevent from becoming contaminated. As AHC Media reveals, “M. chimaera is exceedingly difficult to detect, treat, and eradicate from devices, shrugging off both antibiotics in humans and powerful disinfectants in machines.”

    Possible symptoms of an M. chimaera infection include:

    Redness, heat, or pus near the site of a surgical incision
    Night sweats
    Persistent or unexplained fever
    Unexplained weight loss
    Chronic fatigue
    Difficulty breathing
    Joint pain
    Abdominal pain
    Persistent cough

    If you or a loved one have undergone surgery where a Stockert 3T Heater-Cooler was used and have any of the above symptoms, you should contact an experienced team of defective medical device lawyers immediately.

    You can contact us at Hughes & Coleman for a free legal consultation regarding your case using the number above or the convenient contact form adjacent. Do not hesitate; if you think you may have an infection resulting from the Stockert 3T Heater-Cooler following a surgery, contact us today.

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