Deadly infections from 3T Heater-Cooler machines in heart surgeries persist despite fixes
Consensus Summary
The articles detail a deadly flaw in the 3T Heater-Cooler machines used during heart surgeries, where contaminated water tanks can spray Mycobacterium chimaera bacteria into patients' chests. Fay Sherret, an 83-year-old former nurse, died 18 months after her 2015 heart valve replacement surgery due to this infection. Between 2016 and 2022, three other Australians died from similar infections linked to these machines. The TGA briefly suspended the devices but allowed them back after design fixes, though investigations suggest these fixes failed. Eleven Australians were infected between 2015 and 2016, with four deaths, and the TGA received 22 reports of contaminated devices between 2021 and [DATE UNVERIFIED], including four infections and one death. The Prince of Wales Hospital in Sydney initially dismissed the risk in 2014, prioritizing life-saving procedures over infection concerns. Experts argue the devices remain fatally flawed, with over 120 global infections linked to heater-coolers, likely underreported. The first known case occurred in 2008 in Zurich, and the manufacturer, LivaNova, detected the bacterium in its factory in 2014. Despite claims of improved safety, studies show the devices are nearly impossible to clean, and infections continue to occur.
✓ Verified by 2+ sources
Key details reported by multiple sources:
- Fay Sherret, an 83-year-old former nurse, died 18 months after a 2015 heart valve replacement surgery due to Mycobacterium chimaera infection from a 3T Heater-Cooler machine
- Three other Australians died from infections linked to the 3T Heater-Cooler machines between 2016 and 2022
- Eleven Australians were infected by the devices between 2015 and 2016, with four deaths reported
- The 3T Heater-Cooler machines were briefly suspended by Australia’s medical devices regulator but allowed back on the market after design fixes were made
- The TGA approved design fixes for the 3T Heater-Cooler devices in 2016, but an investigation found these fixes did not appear to have worked
- The Prince of Wales Hospital in Sydney stated in 2014 that the risk of infection from the 3T devices was extremely low and no formal escalation or water testing was needed
- More than 120 confirmed infections worldwide have been linked to heater-cooler devices, with experts suggesting the true toll is likely higher due to underreporting
- The 3T Heater-Cooler machines hold several litres of water, which can become contaminated with Mycobacterium chimaera, a bacterium that can be sprayed as a mist into a patient’s chest during surgery
- The manufacturer, LivaNova, claims design updates and disinfection protocols have mitigated the risk, but experts argue the devices remain fatally flawed and should be removed from operating theatres
- The first known case of Mycobacterium chimaera infection linked to the 3T Heater-Cooler occurred in 2008 in Zurich, Switzerland, where a 55-year-old man died 15 days after surgery from progressive heart failure
- The Sorin Group (now LivaNova) detected Mycobacterium chimaera in its factory water supply and production line in August 2014, before the major outbreak began
- The TGA notes that adverse event reports do not prove causation and cannot be used in isolation to assess device safety
Points of Difference
Details reported by only one source:
- An investigation by THEAGE used automated website scrapers to extract about 81,000 publicly available adverse-event reports submitted to the TGA since 2012
- A former infection control specialist at a major hospital described the devices as impossible to clean properly, stating 'God, you could never clean this thing properly.'
- The article mentions a study from 2020 in the Journal of Hospital Infection where Italian doctors found all their devices were infected despite following new disinfection instructions
Contradictions
Conflicting information between sources:
- The Prince of Wales Hospital claims no cases of Mycobacterium chimaera infection have been diagnosed in patients since 2016, despite reports of infections and deaths linked to the devices
- LivaNova states it is unaware of any reports of patient infection associated with an upgraded device in Australia, while the TGA and experts suggest the risk persists
Source Articles
Fiona’s mum died after a heart surgery machine gave her a fatal infection. Hospitals are still using it
After several patient deaths, experts say the machines are fatally flawed and should be removed from Australian operating theatres.
Fiona’s mum died after a heart surgery machine gave her a fatal infection. Hospitals are still using it
After several patient deaths, experts say the machines are fatally flawed and should be removed from Australian operating theatres.