A warning letter sent by the U.S. Food and Drug Administration (FDA) to the maker of a heater-cooler device linked to infections and deaths at York Hospital in Pennsylvania highlights major problems with the company’s cleaning protocol.
Free Heater-Cooler Class Action Lawsuit Evaluation: If you got an infection after undergoing open heart surgery with a heater-cooler device, you should contact our law firm immediately. You may be entitled to compensation by filing a suit against the manufacturer and our lawyers can help.
What’s the problem?
January 6, 2016 – Late last year, WellSpan announced that it had found at least 8 open-heart surgery patients who developed a rare nontuberculous mycobacteria (NTM) infection, 5 of whom died. Penn State Milton S. Hershey Medical Center identified 3 similarly infected patients, 2 of whom have died.
The NTM infections were associated with a heater-cooler device made by Sorin Group, which was recently acquired by LivaNova.
The heater-cooler is not designed to have any direct contact with patients during surgery; however, there is a potential for tainted water to enter other parts of the device or transmit bacteria through its exhaust vent and on to the patient, according to the FDA.
In June, Sorin sent a letter to its customers warning them of the potential risks and new cleaning and disinfection procedures after heater-cooler infections were reported in Europe.
The warning letter states that the FDA performed inspections at Sorin’s facilities and determined that the company failed to provide adequate information regarding how its new cleaning procedures prevent biofilm from growing in the heater-coolers or causing waterborne infection.
The letter goes on to state that the FDA is “taking steps to refuse entry of these devices into the United States … until these violations are corrected.” The agency requested that LivaNova respond within 15 business days with specific steps to correct the violations.
Do I Have a Heater-Cooler Class Action Lawsuit?
The Medical Device Litigation Group at our law firm is an experienced team of trial lawyers that focus on the representation of plaintiffs in heater-cooler lawsuits. We are handling individual litigation nationwide and currently accepting new infection cases in all 50 states.
Free Confidential Case Evaluation: Again, if you or a loved one got a heater-cooler device infection after open heart surgery, you should contact our law firm immediately. You may be entitled to compensation by filing a class action suit and our lawyers can help.