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Stockert 3T Heater-Cooler Case Awaits Consolidation Decision

Stockert 3T Heater-Cooler Case Awaits Consolidation Decision January 29, 2018. By Brenda Craig.
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).
Read [ Stockert 3T Heater-Cooler Case Awaits Consolidation Decision ]

More Stockert 3T Heater-Cooler Lawsuits after Slow-Developing Infections

More Stockert 3T Heater-Cooler Lawsuits after Slow-Developing Infections November 26, 2017. By Jane Mundy.

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.
Read [ More Stockert 3T Heater-Cooler Lawsuits after Slow-Developing Infections ]

Stockert 3T Bacterial Infection Can Linger

Stockert 3T Bacterial Infection Can Linger October 27, 2017. By Jane Mundy.
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.
Read [ Stockert 3T Bacterial Infection Can Linger ]

Children Infected by Stockert 3T Surgical Device at New Orleans Children’s Hospital

Children Infected by Stockert 3T Surgical Device at New Orleans Children’s Hospital September 18, 2017. By Anne Wallace.

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.


The heater-cooler surgical devices, designed to control the temperature of a patient’s blood and organs during heart bypass surgery, have been linked to a host of bacterial infections. Research presented this June at the 44th Annual Conference of Association for Professionals in Infection Control and Epidemiology found potentially deadly Mycobacterium chimaera contamination in 37 percent of the units examined between June 2015 and December 2016. In addition, the study found other non-tuberculous mycobacteria, Legionella, and fungi.


In October 2016, both the Centers for Disease Control  and the Food and Drug Administration specifically warned about the risks to patients posed by the use of Stockert 3T heater-cooler devices during surgery. The FDA blocked imports of the heater-cooler devices at the time. Studies warning of the risk of infection and safety communications regarding use of the heater-cooler devices, however, date back 15 years to 2002


The devices have water tanks that provide temperature-controlled water during surgery through closed circuits. The water in the instrument does not come into direct contact with the patient, but it can aerosolize through the device’s exhaust vent. The aerosol, if contaminated, may transmit bacteria to the patient. Disinfection of the closed circuit systems has proved to be problematic. Symptoms of bacterial infection arising from the contaminated units may include fever, fatigue, pain, nausea, vomiting, and weight loss. These may be particularly dangerous in very young and very vulnerable pediatric patients.


Stockert 3T lawsuits arising from the infections at the New Orleans Children's Hospital could potentially target both the manufacturer for negligent design or production of the devices and the hospital, for professional malpractice, since it had notice of the risk of infection and the need for careful decontamination long before the surgeries occurred. If the parents choose to litigate, these lawsuits will join a host of other Stockert 3T infection lawsuits now pending in in the U.S. and Canada, some of which seek class action certification.
Read [ Children Infected by Stockert 3T Surgical Device at New Orleans Children’s Hospital ]

Heart Surgery Patient Blames Stockert 3T Heater-Cooler System for Infections

Heart Surgery Patient Blames Stockert 3T Heater-Cooler System for Infections August 22, 2017. By Jane Mundy.
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.
Read [ Heart Surgery Patient Blames Stockert 3T Heater-Cooler System for Infections ]

Study Finds That Heater-Cooler Devices Used in Surgery Could Be Contaminated

Study Finds That Heater-Cooler Devices Used in Surgery Could Be Contaminated July 29, 2017. By Deb Hipp.
Pittsburgh, PA: A new study by a Pittsburgh scientific researcher has found that more than one-third of heater-cooler devices used in open-heart surgery could be contaminated with dangerous bacteria.
Read [ 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?

Is the FDA Doing Enough to Prevent Stockert 3T Heater-Cooling Device Infection? June 5, 2017. By Jane Mundy.
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 [ Is the FDA Doing Enough to Prevent Stockert 3T Heater-Cooling Device Infection? ]

South Carolina Stockert 3T Lawsuits Won't Head to MDL

South Carolina Stockert 3T Lawsuits Won't Head to MDL May 22, 2017. By Deb Hipp.
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 [ South Carolina Stockert 3T Lawsuits Won't Head to MDL ]

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 May 2, 2017. By Jane Mundy.
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 [ Stockert 3T Not the Only Heater-Cooler Unit Associated with Infection discovered Years Ago ]

Australian Researchers Urge Sharing Data On Contaminated Medical Devices

Australian Researchers Urge Sharing Data On Contaminated Medical Devices April 17, 2017. By Deb Hipp.
Waltham, MA: Three University of Melbourne researchers have recently published a letter to the editor in the New England Journal of Medicine voicing concern that thousands of patients worldwide could be exposed to contaminated medical devices.
Read [ Australian Researchers Urge Sharing Data On Contaminated Medical Devices ]


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