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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

A lawsuit has been filed against LivaNova PLC (formerly Sorin Group Deutschland GmbH), the manufacturer of the Stockert 3T heating-cooling system, alleging failure to warn hospitals and doctors of the increased risk of infections caused by the medical device during cardiothoracic surgeries, according to Philly.com. The FDA reports that Sorin had received complaints about patient deaths related to nontuberculous mycobacterium (NTM) and the devices since January 2014. (M. chimaera is a type of NTM that can cause serious illness or death).

Stockhert diagram
Fig. 1 - FDA schematic
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

Heater-cooler devices like the Stockert 3T are often used during surgeries, particularly cardiac procedures. The device controls a patient’s body temperature with the intention to improve medical care and patient outcomes. Heater-cooler devices include water tanks that provide temperature-controlled water to heat exchangers or blankets, which then provide cooling or warmth to the patient's body. Water in the circuits does not directly contact the patient. There is potential, however, for contaminated water to enter other parts of the unit or to aerosolize, transmitting bacteria through the air and through the device’s exhaust vent into the environment and to the patient.

Other devices are warming/cooling blankets through closed circuits, such as the Bair Hugger warming blanket.

Stockert 3T Infection

Nontuberculous mycobacteria infections (NTM) have been most associated with the Stӧckert 3T system. The Stӧckert 3T heating, warming, cooling device has been implicated to be causing a new strand of rare bacterial infection known as M. chimaera. This bacteria has been directly linked to a contamination in the manufacturing of the Stӧckert 3T Heater-Cooler System (3T) by Sorin Group Deutschland GmbH.

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:

  • fatigue
  • difficulty breathing
  • persistent cough or cough with blood
  • fever
  • pain
  • redness, heat, or pus at the surgical site
  • muscle pain
  • joint pain
  • night sweats
  • weight loss
  • abdominal pain
  • nausea
  • vomiting

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 Help

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STOCKERT 3T LEGAL ARTICLES AND INTERVIEWS

Is the FDA Doing Enough to Prevent Stockert 3T Heater-Cooling Device Infection?
Is the FDA Doing Enough to Prevent Stockert 3T Heater-Cooling Device Infection? Washington, DC: The FDA warns that M. chimaera infection may take months or even years to develop. Ironically, after sitting on reports of infection associated with the Stockert 3T heater-cooler system and similar systems during open chest surgeries, it takes the agency months or years to warn the public [READ MORE]

South Carolina Stockert 3T Lawsuits Won't Head to MDL
South Carolina Stockert 3T Lawsuits Won't Head to MDL Greenville, SC: The U.S. Judicial Panel on Multidistrict Litigation (JPML) will not allow a large group of federally filed lawsuits concerning the Stockert 3T heater-cooler system to be consolidated in one court for more efficient handling [READ MORE]

Stockert 3T Not the Only Heater-Cooler Unit Associated with Infection discovered Years Ago
Stockert 3T Not the Only Heater-Cooler Unit Associated with Infection discovered Years Ago Washington, DC: Over the past few years the Stockert 3T heater-cooler system has come under fire after reports of heart bypass patients developing Mycobacterium chimaera infections were traced back to the device. But Stockert isn’t the only heater-cooler system in use [READ MORE]



READER COMMENTS

Posted by
nancy
on
If you have no symptom a year after open heart surgery with this equipment, how do you get tested for presence of this bacteria in your bloodstream/body? Is there a test / place for this?

Posted by
Raymond Meyers
on
I had open heart surgery (Quintuple bypass) in which the Sorin 3T was used – in December of 2013. I have been notified of the risks and possibilites. by the hospital at which the surgery was performed.

I have had multiple health issues since – some of which remain undiagnosed. Because the issues are undiagnosed, I have been unable to obtain any disability support from Social Security.

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