Sigma Spectrum Infusion Pump Model 35700: Class 1 Recall: Risk of Over-Infusion
MedSun: Newsletter #55, December 2010

FDA MedWatch Safety Alert

Affected units may fail suddenly, causing inaccurate flow conditions during use, ranging from back flow to over-infusion, including free flow. The pump does not issue an alarm when this occurs. These conditions could result in serious injury or death. Sigma has instructed healthcare facilities to verify whether the serial numbers for their infusion pumps fall within the range of pumps being recalled and is requiring the return of the recalled devices. Sigma has instructed users to not use the infusion pumps on patient populations, including neonatal patients, where inaccurate flow, ranging from back flow to over-infusion, including free flow, could result in serious adverse health consequences or death.

Additional Information:

FDA MedWatch Safety Alert. Sigma Spectrum Infusion Pump Model 35700: Class 1 Recall: Risk of Over-Infusion. November 12, 2010.
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm233747.htm


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