Blood bag supplier: Specks are 'blood-derived'
Red Cross wants nationwide inspection for white particles
By Debra Goldschmidt
WASHINGTON (CNN) -- The company whose containers are the suspected origin of white particles found in donated blood said Monday that its preliminary tests indicate the specks are "blood-derived in nature, likely a very small fibrin clot containing white blood cells and platelets."
Hours earlier, the Red Cross had asked its regions throughout the country to inspect their supplies of donated blood for signs of the white specks, which had been found in two Southeast regions.
In a written statement issued Monday afternoon, Baxter International Inc. said the particles are natural components of blood "which occur to varying degrees in stored blood under normal conditions."
The American Red Cross said it suspected the Baxter bags were causing the problem because the specks were not found in any other type of container.
Mary Malarkey, director of the Food and Drug Administration's case management division, said the FDA is "actively investigating the case," deploying people to investigate "all points involved." She said investigators will study the manufacturing and handling of the containers, and even weather conditions in the Southeast.
She said it was too soon to draw conclusions and added that the agency has not ruled out anything.
White specks were first found last week in bags of donated blood in the region covering Georgia and northern Florida. The problem appeared limited to about 4,000 bags manufactured by Baxter.
More particles were discovered Sunday in the Tennessee Valley Region. The Red Cross ordered the region, which covers middle Tennessee and parts of Illinois, Kentucky and Missouri, to quarantine 70 percent of its blood supply after the specks were found in 10 bags manufactured by Baxter.
Regional spokeswoman Patricia Smith said the substance in the blood is easy to see and "looks like granulated sugar of different sizes."
No problems have been found with blood in bags made by other manufacturers, Smith said.
The Centers for Disease Control and Prevention said the Georgia blood tested negative for infectious agents. Tests for non-biological material are under way.
A Baxter spokeswoman said Friday that after an investigation of samples received from the Red Cross, "we believe that all Baxter blood pack units are safe for use." She said the company was still collecting information.
The Red Cross has said it believes the contamination will be traced to the bags.
So far there have been no reports of adverse reactions from the contaminated blood, but Smith said it is not known whether any patients received that blood.
Hospital predicts 'dire straits' soon
There have been no reports of surgeries in Tennessee being canceled because of the quarantine. Blood is being imported to replace the quarantined units. Ninety-nine units were received from Detroit, Michigan, on Sunday, and three more shipments from Illinois, Maine and Wisconsin were scheduled to arrive Monday. Donation hours in the area have been extended through Wednesday.
Dr. Ann Neff, director of transfusion services at Vanderbilt Medical Center in Nashville, Tennessee, said Monday that the hospital is able to run its regular schedule, but it goes through blood quickly and could be in "dire straits as early as tomorrow."
Neff said she is "hopeful if not confident that we'll be fine" and said the Red Cross had filled the hospital's blood order. She said patients who donated blood for use during their own surgery or those whose family members donated blood for them are affected by the quarantine if the blood was collected in Baxter bags.
"They all have the option of getting blood from the donor supply, or, if their surgery is elective, they can decide to reschedule," she said.
The Red Cross Blood Services Southern Region reported a 25 percent increase in donations during the weekend after hospitals in Georgia were urged not to use the contaminated blood Thursday and many elective surgeries were canceled. That region received 2,600 units of blood from across the country last weekend, according to Marcy Blount in the Southern Region office.