Hospital notifies heart surgery patients about possibility of co - WFSB 3 Connecticut

Hospital notifies heart surgery patients about possibility of contaminated device

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The FDA says "heater-cooler devices are often necessary for use during surgeries to warm or cool patients as part of their care." (www.fda.gov) The FDA says "heater-cooler devices are often necessary for use during surgeries to warm or cool patients as part of their care." (www.fda.gov)
HARTFORD, CT (WFSB) -

Three thousand patients who underwent an open-heart procedure during the past few years at Saint Francis Hospital now have a risk of infection.

This is all because of a medical device used in the surgeries was recently recalled.

The Centers for Disease Control said the brand, Stockert 3T, may have been contaminated during manufacturing, and therefore could cause infection.

It is basically a heating-cooling unit used during open-heart surgeries to control a patient’s body temperature.

The device has been used at thousands of hospitals across the country, including Saint Francis, which is in the process of replacing the at-risk equipment.

Officials said they want to make it clear the risk of getting an infection is very low, but they wanted to get the word out.

Those who have had an open-heart surgery at Saint Francis between Jan. 1, 2012 and Nov. 17, 2016, and who have symptoms including night sweats, muscle aches, weight loss, unexplained fever or drainage or redness of the surgical wound, are asked to call the hospital.

The decides are not used at Hartford Hospital. Eyewitness News also checked with Yale-New Haven Hospital but hasn’t heard back yet.

Saint Francis Hospital issued more information on Thursday, saying “With the care and safety of our patients and our colleagues as our highest priorities, Saint Francis Hospital and Medical Center has taken many important steps to address potential contamination issues with these devices, including:

  • Complying with CDC and manufacturer recommendations for ensuring safe use
  • Implementing enhanced disinfection practices for minimizing the risks to our patients even more
  • Notifying patients and families about potential risk
  • Replacing the at-risk equipment. We currently have 5 Sorin devices and are expecting delivery of replacement devices from a different manufacturer this month
  • Prior to surgery, Saint Francis proactively and fully discloses the known risks and benefits for all patients who need a procedure requiring the use of this equipment. We are currently working to alert approximately 3,000 adult patients who underwent an open heart procedure during the past several years about their very small risk of infection. Additionally, we have ensured our clinical teams are fully aware of the risks and the symptoms that could indicate the need for treatment or assessment for possible infection.

Anyone looking for more information on this can check the CDC website here, or call their provider to schedule an evaluation.

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