AUDIENCE: Risk Manager, Nursing
ISSUE: Hospira identified that an incorrect set component was
supplied and used during the manufacturing process of the impacted product lots. The Hemostat Dual Channel Plum Set is 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. These injuries are expected to fully resolve with medical intervention.
BACKGROUND: The blood sets impacted by the recall (list number 11241-03, lot numbers 28005-5H and 34100-5H)were distributed to U.S. healthcare and veterinary facilities from May 2013 through Dec. 2013.
RECOMMENDATION: Customers should check inventory and immediately quarantine any affected product. In addition, customers should inform potential users of this product in their organizations of this notification. Affected product should be returned to Stericycle.
Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:
- Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
- Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
[03/18/2014 –Press Release- Hospira]