CareFusion Alaris PC Unit, Model 8015: Class I Recall
MedSun: Newsletter #76, September 2012

FDA MedWatch Safety Alert

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.

Additional Information:

FDA MedWatch Safety Alert. CareFusion Alaris PC Unit, Model 8015: Class I Recall. August 1, 2012.
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm314090.htm


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