The CareFusion Alaris PC Unit, Model 8015, is subject to a Class I recall because a component on the PC unit power supply board is causing an error code (120.4630): "System Error" or "Missing Battery Error" to occur. The error code is accompanied by both an audible alarm and a visual error message on the PC unit screen. If the error code occurs at start-up, the Alaris infusion pump cannot be programmed and this may cause a delay in patient therapy. If the error code occurs during infusion, the health care provider cannot make programming changes to current infusions, and this may result in serious injury and/or death to the patient.
The Alaris PC unit, model 8015 is part of the Alaris electronic infusion pump. Electronic infusion pumps deliver controlled amounts of medications or other fluids to patients through intravenous (IV), intra-arterial (IA), epidural, and other acceptable routes of administration. The affected infusion pumps were distributed from January 1, 2011, to May 31, 2012.
The manufacturer recommends clinical areas administering high-risk infusions consider having additional infusion pumps as back-up until the recalled infusion pumps are fixed.
Class I recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death.
See the recall