Important News for Open Heart Surgery Patients in SeattleWhen people visit hospitals, especially when it’s for something as serious as open heart surgery, they trust that the doctors and nurses there will give them the best care possible. Unfortunately, sometimes things can go wrong, and that’s most recently been the case with a device known as the Sorin Stockert 3T heater-cooler system.
The device is used during open heart surgeries to regulate a patient’s body temperature by raising or lowering it as needed. The Sorin Stockert 3T is one of many devices that are used for this purpose in these surgeries, and in 2015, the FDA issued a release stating that some of these devices were linked to causing nontuberculous mycobacterial (NTM) infections in patients. In June 2016, the news got worse for Sorin as the Stockert 3T was mentioned specifically in another release by the FDA. It had been found that some patients who had this device used in their open heart surgeries had come down with an NTM infection.
Of course, patients who have experienced complications from their surgeries that used the Sorin Stockert 3T might be able to hold the company partially to blame. The FDA has issued warnings to Sorin stating, “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,” clearly indicating that there was a problem with the device. The FDA also stated in a letter that “the cause of infection appeared to be 3T devices colonized with mycobacteria.”
Both of these statements clearly indicate that Sorin was made aware of the problem by the FDA, and if they continued to sell them to hospitals, they could be held accountable. However, hospitals have also been warned about the devices by the FDA, and have been advised to discontinue their use. If the hospital failed to do so, they could also be held accountable for any infections, injuries, or other complications from surgery that arise as a result of using the Sorin Stockert 3T heater-cooler system.
At Hardwick & Pendergast, P.S., we’ve started taking Seattle cases regarding the Sorin Stockert 3T heater-cooler system. If you’ve had open heart surgery and think you’ve been affected, we want to hear from you. Call us toll-free at (888) 228-3860 for a free initial review of your case. Our experienced surgical malpractice attorneys know all about the problems the Sorin Stockert 3T heater-cooler system can cause, and we want to help you with yours.