19 Mar 2014, BioSpectrum Bureau , BioSpectrum
Singapore: FDA has stated that biologic drug company, Hospira, has identified an incorrect set component supplied and used during the manufacturing process of Hemostat Dual Channel Plum Set, designed to administer blood and blood products via the Plum infusion pump.
If the Plum infusion pump is used with the affected product, the blood product will be delivered at its intended dosage and there is no risk of over-delivery. If the affected product is removed from the Plum infusion pump and used in a gravity infusion, there is a risk that over-delivery may occur. Over-delivery of blood products in the populations at greatest risk (e.g. neonates, patients with heart and/or kidney failure, and other patients with conditions associated with susceptibility to volume overload) may result in injuries that require medical intervention.
The blood sets impacted by the recall were distributed to U.S. healthcare and veterinary facilities from May 2013 through Dec. 2013.