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Defective medical device blamed for man's infection and death

Minimizing the risk of infection is usually one of the top priorities at California hospitals, and staff typically follow strict protocols to help create the safest environment for patients. An out-of-state family claims that a defective medical device compromised a patient's infection-free environment and ultimately caused his death. A product liability suit has since been filed, naming LivaNova, PLC -- the device's manufacturer -- and the hospital as liable parties.

In Dec. 2014, the 62-year-old patient underwent an open-heart procedure and an aortic valve surgery. Less than a year later, he died from complications and an infection linked back to his surgeries. Heater-cooler devices are commonly used during these types of procedures in order to exercise control over the body temperature of patients. The Sorin 3T Heater-Cooler System was used during this and several thousand other patients' surgeries, but it apparently contained a deadly defect.

The hospital became aware of the defect in the system that allows nontuberculous mycobacteria -- NTM -- to develop. Once NTM develops inside of a machine, the bacteria can be aerosolized and spread to the patient undergoing surgery. The slow-acting nature of NTM means that patients who contract the bacteria do not develop symptoms until months after becoming infected, while some even take years to fully begin suffering the ill-effects. Many other patients have contracted NTM from the system, several of whom have died.

The recently filed suit alleges that LivaNova was either aware or should have been aware of the NTM infections from its heater-cooler system because it had discovered that the harmful bacteria could multiply in the device. This was further evidenced in a letter it sent out to hospitals warning of the potential issue. Although it is impossible to bring back a loved one or undo the harm inflicted on a patient by a defective medical device, product liability suits are often effective at achieving just compensation for California victims and their families.

Source:, "Suit filed against device maker, hospital in York infection death case", Paul Smith, June 27, 2016

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