Sorin 3T Heater-Cooler and NTM Infection Timeline
Use the arrows on the left and right side of the timeline slideshow to navigate through its progression.
Infection outbreak at hospital in Greenville, SC
July 21, 2014 – 15 infections and 4 deaths are linked to infections involving non-tuberculous mycobacteria (NTM) at Greenville Memorial Hospital. The initial investigation leads to the temporary removal of heater-cooler devices from the O.R., but the device wasn’t implicated. The CDC later indicated that contamination of the Sorin 3T may have contribute to the Greenville outbreak.
Sorin Group sends Safety Notice to hospitals
July 2014 – Sorin Group USA, Inc. is the 3T heater-cooler manufacturer that provides the majority of heater-cooler devices used throughout U.S. hospitals. The Colorado-based company states that it sent Field Safety Notice to facilities notifying them of a possible link between their device and NTM infections.
Sorin’s inspection finds contamination at plant
August 2014 – Testing conducted by the Sorin Group in August 2014 found M. Chimaera contamination on the production line and water supply at the 3T heater-cooler device’s manufacturing plant.
NTM infections identified in PA hospital
July 2015 – WellSpan York Hospital works with PA’s health department and the CDC to identify the extent of infections and determine associated risk factors and exposures to prevent further infections.
FDA inspections reveal Quality Systems Regulation violations
August 24, 2015 – The FDA conducts inspections at Sorin’s Munich, Germany and Arvada, Colorado manufacturing plants and finds multiple Quality Systems Regulation violations, a part of the Federal Food, Drug and Cosmetic Act.
Sorin updated the cleaning and disinfection procedures for heater-coolers at its manufacturing plant
September 2015 – Sorin added cleaning and disinfection procedures to the production line for heater-coolers.
The FDA sends medical providers a notification for heater-cooler units
October 15, 2015 – The FDA sent a nationwide Safety Communication which highlighted potential links between NTM infections and heater-cooler devices. This notice also informed hospitals to follow the updated cleaning/disinfection instructions provided by Sorin.
WellSpan in PA alerts its at-risk patients
October 26, 2016 – Towards the end of October 2015, WellSpan York Hospital notified approximately 1,300 patients who had open-chest surgery about the potential risk of contracting an NTM infection. By this time, York Hospital identified 8 patients with infections, 4 of which died.
FDA sends warning letter to Sorin Group
October 29, 2015 – FDA immediately prohibits importation of 3T heater-cooler devices to the U.S. Existing users are not directed to cease using the devices. The FDA also reported that the 3T Systems are adulterated and misbranded, and lacked requisite safety validation for several design changes to both the device itself as well as a series of revised disinfection instructions.
NTM infections reported in Michigan hospital
November 2015 – In Grand Rapids, MI, Spectrum Health Medical Center identified that all 7 of their heater-cooler devices were contaminated with NTM. The hospital identified 2 patients with NTM infections, and alerted their open-chest surgery patients.
Hershey Medical Center identifies NTM infections
November 9, 2015 – Penn State Health’s Milton S. Hershey Medical Center discovered 3 patients who contracted NTM infections, 2 of which died. This caused the hospital to alert approximately 2,300 open-chest surgery patients.
NTM infections found in Iowa hospital
February 2016 – In Iowa City, IA, University of Iowa Hospitals and Clinics identified 1 patient with an NTM infection and alerted approximately 1,500 patients who had undergone open-chest surgery.
FDA Field Safety Communication Update
June 2016 – The FDA informs medical facilities that they should be on alert if they used a 3T heater-cooler prior to September 2014, units may have been shipped from the factory contaminated with M. chimaera. If a facility used a 3T heater-cooler after September 2014, it should continue to follow the recommendations provided in FDA’s 2015 Safety Communication and the manufacturer’s most current instructions.
FDA holds Advisory Committee Meeting on 3T heater-coolers
June 2, 2016 – In early June 2016, the FDA held an Advisory Committee Meeting with medical experts to discuss the potential links and dangers between heater-cooler units and NTM infections.
NTM infections found at 2nd Iowa hospital
August 2016 – Two patients were identified to have NTM infections at Mercy Medical Center in Des Moines, IA. Mercy Medical proceeds to alert approximately 2,600 open-chest surgery patients.
Philadelphia hospital reports NTM infections
September 19, 2016 – Four NTM infections were discovered in patients at Penn Presbyterian Medical Center in Philadelphia, PA. The hospital alerted their open-chest surgery patients regarding the potential link between NTM infections and heater-cooler devices.
LivaNova Issues Field Safety Notice Update
October 13, 2016 – Sorin Group reports CDC findings in Morbidity and Mortality Weekly Report. Tests conducted by the CDC and National Jewish Hospital show a genetic similarity between patient and heater-cooler strains of the NTM bacteria M. chimaera isolated in Iowa and Pennsylvania hospitals. There may be a shared point source for the isolated NTM bacteria.