FDA cites Fresenius Kabi for contamination problems that CDC linked to deadly sepsis cases

Several cases of sepsis — three of which ended in patients deaths — were traced to a Fresenius Kabi manufacturing plant in a new report from the U.S. Centers for Disease Control and Prevention. And the findings were released a year after the U.S. Food and Drug Administration cited the company for contamination problems and other quality control issues at the same facility.

The findings stemmed from a multi-state investigation of seven sepsis cases transmitted during blood transfusions. Samples collected between 2018 and 2022 led researchers to platelet collection products made by the company at a plant in Puerto Rico. Ultimately, the facility was the “most probable” source of the cases, according to the report in the CDC’s Emerging Infectious Diseases journal.

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Bacterial contamination of platelet components commonly occurs during blood collection and typically involves a single identified species of bacteria. But “multiple episodes” of different bacteria contamination “with identical bacterial species in platelet components across different states is exceedingly rare, suggesting a possible common source of contamination,” the researchers wrote.

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