The U.S. Food & Drug Administration (FDA) is warning about an increased risk of bacterial infections associated with use of the Stӧckert 3T heater-cooler device made by Sorin, known as LivaNova since its merger last year with Cybertronics.
Free Confidential Lawsuit Evaluation: If you suffered an infection or other injury after undergoing surgery in which a heater-cooler device was used, 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.
Update: Heater-Cooler Machines Contaminated at German Plant, Study Finds
July 15, 2017 – Contamination at a German factory that makes heater-cooler devices is the likely source of a global outbreak of deadly infections tied to the devices, a new study has found. Researchers using whole-genome sequencing matched the DNA of samples taken from contaminated heart surgery patients in several countries to samples from heater-cooler units in multiple hospitals and at the production site.
What’s the Problem?
June 1, 2016 – According to the FDA, a European study linked cases of infection by mycobacterium chimaera (PDF) to samples taken from German-made Stӧckert 3T heater-cooler devices that were used during heart surgeries.
“The results of this paper suggest a direct link between the M. chimaera to which the European patients were exposed and became infected during open-chest cardiac surgery, and 1 specific heater-cooler model – the 3T,” the agency said. “FDA believes these [nontuberculous mycobacterium] infections associated with the 3T are rare. However, they are difficult to detect because patients infected with M. chimaera may not develop symptoms and signs of infection for months to years after initial exposure.”
Tests performed by Sorin in 2014 found that the bacteria had contaminated the facility’s production line and water supply; updated cleaning and disinfection protocol were instituted as a result, and subsequent testing indicated no sign of the bug, according to the FDA.
“The FDA has received reports of U.S. patients infected with M. chimaera after undergoing cardiothoracic surgery that involved the use of the 3T. Currently, efforts are underway in the U.S. to determine if the infections in U.S. patients and M. chimaera isolates from samples taken from the 3T are linked with M. chimaera isolates from European patients who were infected and the M. chimaera previously identified at the 3T manufacturer’s production and servicing facility in Germany,” the agency said, advising caregivers to monitor patients for symptoms of the infection.
At least 32 infections associated with heater-coolers have been reported to the FDA, including 25 received last year. The devices use water tanks to provide temperature-controlled water to keep patients warm or cool during surgery. Although the water does not come into contact with patients, the agency warned that contaminated water could enter other parts of the device, which could then be sprayed through its exhaust vent.
In a warning letter issued to Sorin last December, FDA flagged the manufacturer over the Stӧckert 3T heater-cooler, noting design changes related to reducing biofilm and bacterial growth.
Study Finds Over One-Third of Heater-Coolers Contaminated
July 6, 2017 – A new study suggests that more than one-third of Stӧckert 3T heater-cooler devices may be contaminated with harmful bacteria such as M. Chimaera, legionella and Nontuberculous mycobacteria (NTM). The results of the study were presented at the 44th Annual Conference of the Association of Professionals in Infection Control and Epidemiology (APIC).
Illinois Man Alleges Sternal Wound Infection from Stockert 3T Heater-Cooler
April 19, 2017 – A man who claims he developed a sternal wound infection after having open-heart surgery with a Sorin Stӧckert 3T heater-cooler device has filed a products liability lawsuit against LivaNova PLC in the U.S. District Court for the District of Illinois. Plaintiff alleges that the manufacturers failed to adequately warn about the risk of contamination from the heater-coolers, and that they intentionally withheld information in order to maximize profits.
Heater-Cooler MDL Rejected
April 10, 2017 – The U.S. Judicial Panel on Multidistrict Litigation (JPML) has ruled that federal lawsuits alleging infections and other injuries from Sorin Stӧckert 3T heater-cooler systems will not be centralized for pretrial handling. The panel stated that South Carolina’s 3T Heater-Cooler docket is already undergoing successful informal coordination, and that none of the parties to lawsuits filed outside of South Carolina supported the MDL.
LivaNova Objects to Heater-Cooler MDL
March 24, 2017 – LivaNova has filed a petition with the JPML opposing consolidation of lawsuits alleging infections from Stӧckert 3T heater-cooler units, saying it would not “promote the just and efficient conduct of these actions.” The company argues that consolidation is inappropriate due to specific issues in each case regarding hospitals, bacteria and patients.
Indiana Hospitals Warn Heart Surgery Patients About Risk of Heater-Cooler Infections
January 3, 2017 – Several Indiana hospitals are warning thousands of open heart surgery patients about a risk of NTM infection linked to heater-cooler systems used during the procedure. Franciscan Health sent letters to 800 patients at its hospitals in Indianapolis, Crown Point and Lafayette who were treated with Stöckert 3T heater-coolers. Community Health Network notified about 600 patients of Community Heart and Vascular Hospital, and the Richard L. Roudebush VA Medical Center contacted 430 patients.
LivaNova Heater-Coolers Linked to Bacterial Infections in Heart Surgery Patients
October 14, 2016 – Over 500,000 patients in the U.S. who had open-heart surgery with a LivaNova heater-cooler device could be at risk for a deadly bacterial infection, according to an FDA Safety Communication issued Thursday. Over the past year, at least 28 NTM infections in patients undergoing open-heart surgery in U.S. hospitals have been linked to the devices. Infections have also been reported in Europe, with some patients diagnosed nearly 4 years after surgery.
Bacterial Infection Death Prompts Heater-Cooler Lawsuit Against LivaNova
June 29, 2016 – A lawsuit was filed last week in Pennsylvania’s York County Court of Common Pleas on behalf of David Inners, who died on November 7, 2015, from a bacterial infection after undergoing open heart surgery with a LivaNova heater-cooler at York Hospital on December 14, 2014. According to the lawsuit, LivaNova designed a device that “prevented it from being reliably and consistently cleaned, disinfected, and maintained,” and that the heater-cooler device is neither safe nor effective. Meanwhile, WellSpan Health was “negligent and reckless” in its care of the device.
Were You Injured by a Heater-Cooler Device?
If you think you developed an infection or other injury from a heater-cooler device, but have not been tested or officially diagnosed, we can help get you the information you need. Contact us today to learn more.
Do I Have a LivaNova Heater-Cooler 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 injury and death cases in all 50 states.
Free Confidential Case Evaluation: Again, if you were injured or infected by a heater-cooler device, you should contact our law firm immediately. You may be entitled to compensation by filing a suit and we can help.