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   SD Plasma, a blood product, made by VI Technologies has been linked to as many as 16 patient deaths across the country. This number is more than twice the number first acknowledged by government officials earlier this year.

   Among the cases newly identified by the Long Island newspaper, Newsday, were three deaths at the University of Chicago Hospitals in 1999. Blood bank workers at the hospital decided to investigate the deaths of three patients who were transfused with the plasma. The patients: two women, ages 28 and 52, and a man, 66 developed blood clots that were not a normal outcome of their health problems.

   Newsday had previously reported that six liver transplant patients at Cedars-Sinai Medical Center in Los Angeles died after receiving SD Plasma. Newsday also identified another six deaths assoicated with SD Plasma this summer. The Food and Drug Administration also identified another four deaths linked to the blood product.

   In all 16 cases, the blood plasma was listed as the primary suspect medication in death reports submitted to the FDA. V.I. Technologies manufactured the plasma for the American Red Cross, which sold it to hospitals across the country.

   The plasma is known as SD plasma because of the solvent detergent scrubbing method used to cleanse it of dangerous viruses. However it is believed that this solvent caused deadly blood clots to form.

   Clotting wasn't the only problem associated with some of the SD plasma transfusions. Two patients received units of SD plasma from batches contaminated with parvovirus B19, which can be dangerous to infants, pregnant women and people with poor immune systems, FDA records show. The FDA recalled 90,000 units of the contaminated plasma in 1999.

   Transfusion experts say it now appears the solvent detergent process used to rid SD plasma of dangerous viruses depleted the normal amount of a substance it contains called Protein S. Scientists believe the reduced amount of Protein S may have contributed to the clotting problem. FDA officials knew about the reduced Protein S levels in SD plasma when they approved it in 1998.

Other Names:
Blood Transfusion Injuries

Adverse Effects/ Potential Injuries:
Blood Clots
Death

Related Terms:
Blood Transfusion
American Red Cross

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