FDA Probes Tainted Blood

Federal health officials are examining blood bag manufacturing and blood collection sites in an attempt to discover the source of white particles found in donated blood in parts of the Southeast.

The maker of the blood bags says the particles are natural components of blood and not a fault of the bags. No health problems have been reported but blood supplies are affected from northern Florida to the lower Ohio Valley.

The particles were found in six lots of blood from the Red Cross' Tennessee Valley Region and 20 from the Southern Region, which includes Georgia and northern Florida. The blood was in bags made at Baxter International Inc.'s Puerto Rican plant, the U.S. Food and Drug Administration said.

"We will review all manufacturing records, storage and data, everything that occurred regarding these units of blood and the lots involved," said Mary Malarkey, director of the FDA's division of case management. "We have not made a determination what the cause is and have not ruled anything out."

The investigation began Thursday when the Red Cross asked hospitals in Georgia and northern Florida to stop using recently collected blood because 110 blood units appeared to be contaminated with some kind of particles.

Ten more units of contaminated blood were found Sunday in the Nashville, Tenn., region, and the Red Cross quarantined 70 percent of the Tennessee Valley Region's blood inventory. The region includes 84 counties in Tennessee and parts of southern Illinois, southwest Kentucky and eastern Missouri.

Baxter officials said the particles were not related to the manufacturing of the bags, but were from "natural components of blood, which can occur to varying degrees in stored blood under normal conditions."

A preliminary analysis "indicates that the particulate matter is blood-derived in nature, likely a very small fibrin clot containing white blood cells and platelets," according to a company statement Monday. Fibrin is a fibrous blood protein that has a role in blood clotting.

FDA officials said tests by the FDA, the Red Cross and the Centers for Disease Control and Prevention were still under way. The Red Cross said tests had shown the particles were not infectious.

FDA officials did not know how many people have received blood that may have the problem with the particles. The Georgia Division of Public Health said Monday that people who received blood from affected bags have not reported any adverse effects.

The Red Cross shipped blood products from other states to Georgia and Tennessee to alleviate the quarantine-caused shortage, Red Cross officials said. Some Georgia hospitals have postponed elective surgeries.

In Tennessee, some areas said they were dangerously low on red blood and plasma.

"It's a near-critical situation right now," said Dr. Brian Carlson, a Red Cross regional medical director. He said he had only a single unit of O-negative blood Monday afternoon.

By Daniel Yee