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June 1, 2016: FDA Warns of Association of Bacterial Infections Heater-Cooler System

shutterstock_71283385Bacterial Infections Heater-Cooler System

The FDA issued a Safety Communication informing the public and health professionals of the potential threat of M. chimaera bacterial infections associated with the use of heater-cooler systems in patients who have undergone cardiothoracic surgeries.

Heater-Cooler System Details

Heater-cooler systems are commonly used to provide heated and/or cooled water to oxygenator heat exchangers, and cardioplegia (paralysis of the heart) heat exchangers, to warm or cool a patient’s blood during cardiac surgical procedures, and in warming/cooling blankets.

Danger of Bacterial Infections Heater-Cooler System Association

Heater-cooler system work by distributing temperature-controlled water from a water tank to the exchanger or blanket. The concern with this design is that sometimes, if used improperly, contaminated water may seep into other parts of the device and spread bacteria to the patient, or escape from the device’s exhaust vent into the air and infect the patient through the environment.

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The Weinberg Law Firm is currently assisting individuals injured by medical devices. If you are a loved one has been seriously injured by a medical device, or have in relation to Bacterial Infections Heater-Cooler System, and you have a question concerning your legal rights, please submit our easy-to-use “Legal Case Evaluation Form”, or contact us toll free at 1-877-934-6274 for a free legal case evaluation.

Original Safety Announcement on Bacterial Infections Heater-Cooler System

On October 15, 2015, the U.S. Food and Drug Administration (FDA) publicly confirmed the association between the surgical use of heater-cooler systems and the spread of infections. This announcement revealed that in five-year span, 32 reports were filed with the FDA regarding bacterial contamination of heater-cooler system.

Since issuing this original communication, the FDA has continued to evaluate the causes and risk factors for transmission of bacterial infection associated with heater-cooler systems.

Heater-Cooler System Contamination

In August of 2014, testing conducted by the Sorin Group’s device manufacturer found bacterial contamination on the production line and water supply at the heater-cooler system manufacturing facility. Heater-cooler systems from this facility can be found worldwide.

In September 2014, the manufacturer addressed this contamination by adding cleaning and disinfection procedures to the production line. The FDA reports that samples taken at the same manufacturing facility in June 2015 did not show M. chimaera on the production line, potentially eliminating the production line as a contamination source.

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