The CareFusion Alaris Pump Module, model 8100, is subject to a Class I recall because CareFusion has received reports of customers experiencing motor stalls during infusion. Most of the motor stalls reported have occurred at high infusion rates (typically over 900 ml/hr). However, the possibility of motor stall occurrence at lower infusion rates cannot be ruled out. When a motor stall occurs, the Alaris PC unit and the Alaris Pump Module display the visual error code 242.4030 with an audible alarm that is followed by a termination of infusion. Termination of infusion, especially in high risk patients, could result in serious injury or death.
The Alaris Pump Module, model 8100, is a part used with the Alaris electronic infusion pump system. 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. It is indicated for use on adults, pediatrics, and neonates. The affected infusion pumps were manufactured from August 1, 2010, to July 31, 2011.
The manufacturer recommended facilities administering high risk infusions to high risk patients should consider using alternative devices, if available. If alternative devices are not available, facilities should consider having additional devices immediately available as backup.
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
See also the August 13, Scalpel Weekly News in which the Alaris Pump Model 8015 was recalled due to computer errors potentially causing fatal injuries.