6 liver transplant recipients die after receiving VI Technologies' plasma substitute.

Six patients undergoing liver transplantation have died after receiving VI Technologies' plasma substitute PLAS+SD, the company has announced.

PLAS+SD (pooled plasma, [human] solvent detergent-treated) is an alternative to fresh frozen plasma that is used to control bleeding during extensive surgical procedures and for transfusions in patients with chronic liver disease or certain clotting factor deficiencies. All 6 transplant patients received intraoperative PLAS+SD along with other blood products and all died (at the same unnamed institution) due to thrombotic events or excessive bleeding during the transplant procedure.

"In cooperation with [the US Centers for Disease Control and Prevention] and the US Food and Drug Administration, VI Technologies has issued a warning letter to doctors that those individuals who undergo liver transplantation should be carefully monitored when PLAS+SD is used in this setting," said Fred Darr, MD, director of medical affairs for plasma services of the American Red Cross, which distributes the product for VI Technologies. "Until the investigation has concluded, we ask that caution be exercised when using PLAS+SD."

The Red Cross' sales force also is alerting physicians of the deaths and the need for closer patient monitoring. Additional notification of the deaths was sent to all US transplant centers, blood banks, and customers who have used the product.

The company claims that PLAS+SD is the only virally inactivated plasma substitute available in the US. Fresh frozen plasma is tested for viruses but does not go through any viral inactivation procedures, Darr said. The product also is distributed in Canada, where no deaths have been reported.