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Safety Alert

Important Safety Information: Stockert 3T Heater-Cooler

Recently, government agencies responsible for monitoring medical equipment have noted the potential that patients who underwent cardiac bypass surgery may have been exposed to a very slow growing bacterial infection.

The Centers for Disease Control and Prevention (CDC) is warning that patients who underwent open-heart (open-chest) surgery involving a Stockert 3T heater-cooler may be at risk, as these devices were potentially contaminated during the manufacturing process in Germany, possibly putting patients at risk for M. chimaera infection.

M. chimaera is a widely occurring bacteria. It is a very slow-growing strain of bacteria that can take years to show up in patients who are exposed to it.

More than 60 percent of all hospitals across the United States have utilized the equipment in question, including MultiCare Tacoma General Hospital.  

As soon as we were alerted of the risk of using these devices, a team was assembled to investigate whether any of our patients had been infected. We have directly reviewed more than 4,500 patient records and have found no indications that any of our patients developed this infection and no 3T heater-cooler devices at MultiCare have been identified as contaminated.  We are continuing to monitor the situation and have continued to comply with both the manufacturer’s and the CDC’s recommendations.

The equipment itself has not been recalled.  However, we have discontinued the use of this equipment at our hospitals.

Chances of developing this infection are extremely low, less than 1:10,000.  And to date, no infections of this type have been identified anywhere in Washington state.  Nationwide, fewer than a dozen patients are believed to have developed an infection associated with this equipment.

We have directly informed patients who had surgery involving cardiac bypass equipment at Tacoma General Hospital or Mary Bridge Children's Hospital within the last five years and have alerted community health care providers so they can be aware of this small risk  for any of their bypass-surgery patients.

For more information, see the CDC Health Advisory at https://emergency.cdc.gov/han/han00397.asp and http://wwwnc.cdc.gov/eid/article/22/6/16-0045_article.