Stockert 3T Heater-Cooler System Infection and Stockert Lawsuits
The Stöckert 3T heater-cooler system has been linked to infection during certain surgeries. The 3T medical device helps regulate a patient’s body temperature during surgery and improve patient outcomes, but both the CDC and FDA have issued Stockert 3T Infection warnings, specifically involving M. chimaera , a new bacterial infection. The Stockert 3T unit has been found to transmit bacteria via water into patients, especially during open-chest cardiac surgeries.
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Stockert 3T Lawsuits
Kenneth Piechowski underwent cardiac surgery in December 2014 at Penn Presbyterian Medical Center in Pennsylvania. The procedure was successful but in May he suffered a stroke, which he claims was caused by slow-growing bacteria that came from the 3T device used during his procedure. Piechowski’s lawsuit states that in March 2016, a Penn physician told him his infection likely came from the 3T heater-cooler.
From October 2013 to December 2015, 1,100 patients at the above Medical Center were potentially exposed to deadly bacteria on heater-coolers. Four of those patients tested positive for Non-Tuberculosis Mycobacteria (NTM).
Both LivaNova and hospitals at which they were used are facing lawsuits that claim defective products and negligence. As of October 2016, six hospitals reported infections in Pennsylvania, Iowa and Michigan. Here is a list of the number of at-risk patients who were notified, the number of patients identified with NTM infections, and the dates of surgery:
- WellSpan York Hospital – 1,300 notified; 12 cases; 10/1/11 to 7/24/15
- Penn State Hershey Hospital – 2,300 notified; 5 cases; 11/5/11 to 11/5/15
- Penn Presbyterian Medical Center - 1,100 notified; 4 cases; 10/1/13 to 12/17/15
- University of Iowa – 1,500 notified; 3 cases; 1/1/12 to 1/22/16
- Mercy Medical Center in Iowa - 2,600 notified; 2 cases; 7/1/12 to 7/1/16
- Spectrum Health Medical Center in Michigan – 4,500 notified; 2 cases; 1/1/12 to 11/10/15
The Washington Post (Oct. 13, 2016) reported that as many as 500,000 patients nationwide could be at risk.
Stockert 3T Heating-Cooling System
Other devices are warming/cooling blankets through closed circuits, such as the Bair Hugger warming blanket.
Stockert 3T Infection
Each year the non-profit organization ECRI Institute’s Health Devices Group compiles Top 10 Health Technology Hazards for 2017 list. This list identifies the potential sources of danger that ECRI believes warrant the greatest attention. Number 5 on the list is infection risks with heater-cooler devices used in cardiothoracic surgery. The group notes that these infections can be life-threatening and have resulted in patient deaths.
Stockert 3T Research Swiss researchers reported in Emerging Infectious Diseases (October 2016) that Heater–Cooler Units (HCUs) seem to provide favorable environmental conditions for growth of NTM, in particular M. chimaera. “An intensified cleaning and disinfection protocol failed to prevent growth of NTM entirely but succeeded in preventing detectable aerosolization of M. chimaera…The contamination status of HCUs seems to be influenced by the intensity of maintenance, especially frequency of water changes.” Given this information, lawsuits are also aimed at the hospitals where surgeries took place.
Researchers have found that NTM could become airborne through a vent in the device and land in the chest cavity of someone during surgery.
FDA and CDC Stockert 3T Warnings The FDA and CDC report that the Stockert 3T heater-cooler devices were allegedly contaminated with Mycobacterium chimaera bacteria when they were manufactured in Germany.
August and September 2014: M. chimaera contamination was found during tests at Sorin, the manufacturing facility, meaning that Sorin knew their products were contaminated. The contamination was found on the production line and water supply at Sorin. Units from this facility were shipped worldwide.
October 2015: The FDA issued its first safety communication. It received 32 adverse event reports on heating, warming, cooling devices (not specifically the 3T) and said they were seeing people with NTM infections.
June 2016: FDA reported that the development of M. chimaera infections were linked to the 3T heater-cooler devices made by LivaNova (formerly Sorin).
Oct. 13, 2016: FDA issued a 3T Heater-Cooler warning that provides health officials with additional recommendations on how to prevent the spread of infection. While the FDA says that developing the M. chimaera infection is rare, it warns that the infection may take months or even years to develop.
NTM infection Symptoms Possible signs and symptoms of NTM infection may include:
- difficulty breathing
- persistent cough or cough with blood
- redness, heat, or pus at the surgical site
- muscle pain
- joint pain
- night sweats
- weight loss
- abdominal pain
If you or someone you know have undergone a cardiac procedure and are experiencing any of the signs and symptoms of NTM infection as outlined above, contact your health care provider right away. According to the CDC, there have been a total of 28 confirmed infections. The FDA reports at least 12 patients may have died as a result of the infection. And you may want to seek legal help— Open-heart surgery patients have filed 3T Heater-Cooler System lawsuits against LivaNova and Sorin Group and attorneys are currently investigating Stockert 3T Heater-Cooler System Infection complaints.
Stockert 3T Infection Legal HelpIf you or a loved one has suffered similar damages or injuries, please click the link below and your complaint will be sent to a lawyer who may evaluate your claim at no cost or obligation.
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More Stockert 3T Heater-Cooler Lawsuits after Slow-Developing Infections
St. Paul, MN: Seventeen months after open-heart surgery where a Stockert 3T heater-cooler system device was used, a man died from M. chimaera and doctors associated the deadly infection with the heater-cooler unit. His wife is one of several people who, in the past few months is seeking legal action against the manufacturer.
Plaintiff Danna Brackenbury filed a complaint in September, 2017 in the U.S. District Court for the District of Minnesota against manufacturer Sorin Group Deutschland GmbH and the Sorin Group USA, Inc. After Brackenbury’s husband suffered a heart attack and underwent surgery at Regions Hospital in St. Paul, he developed a slow-growing, Mycobacterium chimaera (M. chimaera) infection. The operative word here is “slow”: the deceased complained to his doctor in July 2016 of fatigue and sudden, rapid weight loss. Two months passed until he was prescribed antibiotics to treat the infection, but it was too late. Hospital doctors confirmed that the Stockert 3T device was used during surgery.
Less than one month after his death the
But the manufacturer knew about the link for several years. And tracking the source of NTM began more than a decade ago in Western Europe hospitals. In 2015 a hospital in Eastern Pennsylvania identified such infections among patients who had undergone open-heart surgery there.
Also in Pennsylvania, a lawsuit was filed in July 2016 against the Stockert 3T manufacturer (the hospital in question is not mentioned). According to the Pennsylvania Record, plaintiff Richard Whipkey underwent an aortic valve replacement in May 2015 and one year later he developed “unexplained symptoms” that lab tests determined was the deadly infection. Richard and Elizabeth Whipkey are requesting a jury trial for both compensatory and punitive damages. The case is: U.S. District Court for the Middle District of Pennsylvania case number 1:17-cv-01233-JEJ.
Several parents have filed complaints against Children's Hospital of New Orleans after their children developed mycobacterium abscessus bacterial infections after undergoing heart surgery this past summer, reported Fox 8 News (Sept 13, 2017). At least one dozen children have been diagnosed with the infection and a hospital spokesperson says that many more children could be infected. The Children's Hospital infections showed up nine months after the CDC warning was issued last October.
Part of the CDC report warned the following: "Although thousands of patients in the United States have been notified regarding potential exposure to contaminated heater-cooler devices, the number who were exposed might be much larger. Over 250,000 procedures using cardiopulmonary bypass are performed in the United States each year.”
Children's Hospital Chief Medical Officer Dr. John Heaton said the hospital had two 'Stockert 3Ts' when they received the CDC report. And one of the devices was involved in the FDA advisory. The hospital has assumed all cost of treatment for families affected by this infection, Fox 8 reported. An attorney for the parents of Children's Hospital patients said that "Our goal and charge is to figure out what Children's Hospital knew, when and what they should have done." The parents may also file a product liability suit against the manufacturer.
Stockert 3T Bacterial Infection Can Linger
- Children Infected by Stockert 3T Surgical Device at New Orleans Children’s Hospital
- Heart Surgery Patient Blames Stockert 3T Heater-Cooler System for Infections
- Study Finds That Heater-Cooler Devices Used in Surgery Could Be Contaminated
- Is the FDA Doing Enough to Prevent Stockert 3T Heater-Cooling Device Infection?
- South Carolina Stockert 3T Lawsuits Won't Head to MDL
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