Newark, N.J. The U.S. Justice Department ordered NMC Medical Products, a division of Fresenius Medical Care North America, to pay a $3.8 million fine to the Food and Drug Administration-the largest ever imposed by the FDA on a manufacturer, according to the U.S. Attorney's Office in New Jersey-for producing faulty components that are used in kidney dialysis systems.

NMC admitted that from Dec. 16, 1992, to Oct. 6, 1993, it manufactured defective "bloodlines"-tubings that carry a patient's blood to and from a dialyzer. The company admitted that it had received reports of blood loss from four patients and 108 malfunctions of those bloodlines during dialysis.

"We are not aware of any deaths or serious injury resulting from the use of bloodlines in question," NMC officials said. "However, there were issues of compliance with federal manufacturing and reporting rules. The company has long since put in place reporting practices and testing procedures designed to prevent this from occurring in the future."

NMC also admitted that it failed to report 1,196 incidents that occurred from November 1992 to December 1994 in which various devices, such as artificial kidneys, bloodlines and other related products, may have caused or contributed to death or serious injury or may have malfunctioned. The company said that it was not aware of the incidents until Dec. 1995.-Richard Park