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Blood bag safety

This article was originally published in The Gray Sheet

Executive Summary

Blood bag manufacturers Baxter, Med-Sec and Terumo are not specifically linked to the formation of white particulate recently found in collection bags in blood centers around the U.S., FDA says. An ongoing investigation initially focused on Baxter bags (1"The Gray Sheet" Feb. 10, 2003, In Brief). The agency notes that the particles are formed from natural substances within the blood and are possibly related to automated methods for platelet collection. The exact cause of particle formation is still unknown...

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FDA is working with Baxter, American Red Cross, CDC and state health authorities to investigate reports of white particulate found in approximately 100 Baxter blood bags. Interim guidance on visual inspection methods of all blood and blood components will be issued shortly, FDA notes Feb. 7, recommending Red Cross procedures such as "placing the bag, label down, on a flat counter undisturbed for 10 minutes and then performing a visual examination for particles." FDA reports receiving a "small number of adverse reports in patients who had also received transfusions utilizing such bags, including one fatality." Baxter said Feb. 3 the particulate is "blood-derived in nature [and] likely a very small fibrin clot containing white blood cells and platelets." Red Cross quarantined 70% of the blood inventory in its southern region and shipped approximately 3,000 new units to Atlanta and 500 units to the Tennessee Valley...

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