The CDC has traced a string of sepsis cases that occurred after blood transfusions to contaminated blood platelet collection sets and solutions manufactured by Fresenius Kabi.
Between May 2018 and November 2022, seven cases of platelet transfusion-transmitted sepsis were identified among patients from six states, according to research published in the agency's Emerging Infectious Diseases journal. Three cases were fatal.
CDC investigators found affected patients all received transfusions that involved collection sets and solutions from Fresenius Kabi. Bacteria isolated from patient and component samples included Acinetobacter calcoaceticus‒baumannii and Staphylococcus saprophyticus.
The FDA inspected the company's manufacturing facilities in Puerto Rico and the Dominican Republic, identifying deficiencies related to environmental controls and sterility. The agency issued a warning letter to the company Sept. 14 over the deficiencies.
"In this investigation, we found that a platelet collection set manufacturer was the most probable source of multiple episodes of polymicrobial contamination of platelet components," the CDC said.
Fresenius Kabi said it will continue to investigate the CDC's findings and has retained outside expert advisers to assist in its review.
"We take the CDC’s findings very seriously, and we share the CDC's goal to protect public health," a spokesperson told Becker's. "As one of the leading developers and manufacturers of products for transfusion medicine and cell therapy, we are committed to working with public health experts, blood collectors, regulators, and others to ensure the safest possible experience for donors and recipients."