STAT+: 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 CDC.
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.
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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