LivaNova Plant Linked to Heart Surgery Infections From Contaminated Medical Devices

Contamination at a German factory that makes crucial machines used during open-heart surgery is the likely source of a global outbreak of deadly infections tied to the devices, the largest analysis to date shows.

Scientists using whole-genome sequencing matched the DNA fingerprints of samples taken from infected heart-surgery patients from several countries, including the U.S., to samples from the devices, called heater-cooler units, in multiple hospitals — and at the production site.

The study, published Wednesday in The Lancet Infectious Diseases journal, concludes that heater-cooler devices made at the LivaNova PLC plant in Munich, Germany, were contaminated during production.

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