The United States Food and Drug Administration (FDA) issued a Class I recall concerning Alaris PC Unit, Model 8015 (part of the Alaris electronic infusion pump), manufactured by CareFusion 303, Inc. The affected unit had power supply board P/N TC 10005122 which were manufactured after January 2011 and were distributed from 1 January 2011 to 31 May 2012.
According to FDA, 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.
For details, please refer to FDA website
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm314090.htm and
http://www.fda.gov/MedicalDevices/Safety/ListofRecalls/ucm314019.htm
If you are in possession of the affected product, please contact your supplier for necessary actions.
Posted on 2 August 2012