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As modern medicine increasingly commits to a reliance on automated devices and machines in the treatment of certain illnesses or physical issues, sometimes the equipment can be linked with serious or even fatal problems.
Such is the case with a machine called the Sorin Stockert 3T heater-cooler system, which is designed to raise or lower the temperature of a patient, based on warming or cooling blood that is being circulated through a heart-lung machine used during cardiopulmonary bypass.
In 2015, the FDA issued a national safety communication regarding heater-cooler devices, which have been linked to dozens of nontuberculous mycobacterial (NTM) infections in patients. The FDA issued an additional safety communication in June 2016 specifically noting Sorin’s Stockert 3T heater-cooler system had been directly implicated in the development of NTM infections in patients who had undergone open-chest cardiac surgery.
On October 13 2016, in an update to its June 1, 2016 Safety Communication, the FDA provides additional information regarding Mycobacterium chimaera (M. chimaera) infections occurring in patients who had cardiothoracic surgeries in which the Stockert 3T Heater-Cooler System (3T) was used to warm or cool their blood. Of particular importance, the update supplies recommendations for health care professionals to assist in prevention of the spread of infection related to this heater-cooler device. To review the complete list of recommendations, click the link to see the updated FDA Safety communication.
The FDA has also issued warning letters to Sorin regarding its heater-cooler devices being adulterated, “in that the methods used in, or the facilities or controls used for, their manufacture, packing, storage, or installation are not in conformity with the current good manufacturing practice requirements…” Among the problems stated in one warning letter, the FDA specifically mentions the company had received several complaints of patient deaths due to NTM infections “where the cause of the infection appeared to be 3T devices colonized with the mycobacteria.”
Weitz & Luxenberg is currently taking cases of patients who have had open heart or chest surgery and developed non-tuberculous mycobacterial infections afterward. Patients suffering from these complications may have cause to pursue litigation and Weitz & Luxenberg would be honored to fight on your behalf.
Mycobacterium chimaera (M. chimaera), a type of nontuberculous mycobacteria bacteria linked to Sorin Stockert 3T heater-cooler devices can cause infections that at one hospitals has carried a mortality rate of 50 percent in affected patients.
Heater-cooler devices are intended for use in patients undergoing surgery involving cardiopulmonary bypass lasting six hours or less.
The FDA wrote in its national safety communication intended for patients and healthcare providers: “Although the water in the circuits does not come into direct contact with the patient, there is the potential for contaminated water to enter other parts of the device or to aerosolize, transmitting bacteria through the air and through the device’s exhaust vent into the environment and to the patient.”
According to a brief prepared for an Advisory Committee held in June of 2016 discussing NTM infections associated with heater-cooler devices, the FDA noted it has received 61 medical device reports from around the world and within the U.S. in which patient infection was reported as potentially related to a heater-cooler device and 119 others in which device contamination was identified.
Infections linked to M. chimaera and other forms of nontuberculous mycobacteria are considered rare, since the bacteria are typically benign and are typically found in soil or water. Unlike other cases of NTM infections, however, those that have been linked with heater-cooler devices, according to the FDA, “represent a very different epidemiological phenomenon” with “a more aggressive pathological profile.”
Because of its potentially lengthy latency period, NTM infection may be difficult to diagnose because it can take months to years after initial exposure to manifest, sometimes with lethal results.
As details of the infections become more widespread, a handful of patients have begun to seek compensation by pursuing civil suits against Sorin, which makes the Stockert 3T heater-cooler system, with more expected to be pursued in the future.
According to a fall 2016 story in the Philadelphia Inquirer, 20 patients who underwent heart surgery in Pennsylvania have been diagnosed with nontuberculous mycobacterial infections linked with heater-cooler machines used during surgery.
The national firm Weitz & Luxenberg has won millions in compensation for clients left injured by faulty medical devices over decades of practice. If a family member has been harmed or killed by a bacterial infection after undergoing cardiothoracic surgery requiring cardiopulmonary bypass in which they were exposed to a Sorin Stockert 3T heater-cooler system, please call (855) 736-6930 or fill out our form for a free consultation.
We would feel privileged to assist you. For a free case review, please contact us todayGet Yours Now