Operating Room Equipment Legal News Articles & Interviews

Santa Clara, CA The chances of developing an infection after cardiac surgery is slim – an estimated 1 in 5,000 patients who had heart valve surgery and even lower for other types of surgery. But that percentage is higher if a Stockert 3T Heater-Cooler was used during surgery. Rod says he hasn’t recovered from his heart surgery and Carol’s husband died from infection. Now they are pursuing a claim against Sorin, the heater-cooler device manufacturer.   

Santa Clara, CA Since M. chimaera contamination was found during tests at Sorin’s manufacturing facility in 2014, and its 3T Heater-Cooler devices subsequently recalled, the FDA has kept close tabs on Sorin, now known as LivaNova.

Toronto, ON A class action lawsuit certified by an Ontario Superior Court judge accuses LivaNova (formerly Sorin), the manufacturer of Sorin 3T Heater-Cooler System, a medical device used to regulate the temperature of fluids during open heart surgeries, of failure to adequately warn hospitals of severe infection risk to open-heart surgery patients.

Minneapolis, MNLawyers and plaintiffs are awaiting an important decision in the Stockert 3T heater-cooler litigation process as the Judicial Panel Multidistrict Litigation (JPML) decides whether or not to consolidate 42 lawsuits into a single federal MDL. Plaintiffs allege the German manufactured operating room device infected some thoracic cardiovascular surgery patients with a potentially deadly strain of bacteria called Mycobacterium Chimera (M. chimaera).

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 FDA released an updated safety communication warning that cardiothoracic surgery with Stockert 3T heater-cooler devices had been linked with M. chimaera infections. And the CDC issued an alert on Oct. 13, 2016, advising U.S. hospitals that used the device to alert patients to the potential for NTM, a rare form of bacteria called non-tuberculous mycobacterium.


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.

Washington, DC: The US Food and Drug Administration (FDA) has provided the medical community with guidance on the use of ultrasonic surgical aspirators. Specifically, the agency is advising companies that make the devices to label them as contraindicated for the removal of uterine fibroids. The non-binding guidance from the agency serves to strengthen its recent warnings about the use of power morcellators to remove uterine fibroids.

Santa Clara, CA: Many warnings, complaints and investigations linking the Stockert 3T heater-cooler system to nontuberculous mycobacteria (NTM) infections and other serious side effects seems to have cooled down. But NTM infections can take years to manifest, and many of the Stockert 3T systems used to regulate body temperature during cardiopulmonary surgeries have not been replaced.

New Orleans, LA:. Officials at Children’s Hospital in New Orleans have acknowledged that a dozen children were infected with mycobacterium abscessus following heart surgery during June and July of this year. Hospital officials fear that more cases may still appear. The source of the infections appears to be a contaminated Stockert 3-T heater-cooler device, and parents are reportedly considering heart surgery infection lawsuits.

Washington, DC: 3M’s , Bair Hugger, the subject of some 2600 defective products lawsuits across the US, has received clearance for use from the US Food and Drug Administration (FDA). According to a spokesperson for the FDA, the agency has no conclusive evidence to establish an association between use of a forced air thermal regulating systems and an increased risk of surgical-site infections.

Toronto, ON:Four years ago David had triple bypass heart surgery and he has been suffering from infections ever since. “Nobody could tell us why he was getting so many infections, until we got a letter from the hospital that said this Stockert 3T heater-cooler system used during surgery is linked to a rare bacterial infection,” says Shelly, David’s wife.