MedStream Programmable Infusion Pump: Class I Recall
MedSun: Newsletter #87, August 2013

FDA MedWatch Safety Alert

The Fill Level Sensor (FLS), a component of the Medstream Programmable Infusion Pump, may malfunction. The FLS is intended to measure the contents of the pump drug reservoir. The malfunction in the FLS may cause the pump’s low reservoir alarm, normally set at 3 ml, to sound too early or too late. Clinicians are directed to evaluate the accuracy of the fill level sensor, during each patient’s next scheduled refill session, or sooner if the patient is symptomatic.

Additional Information:

MedStream Programmable Infusion Pump: Class I Recall. FDA MedWatch Safety Alert. July 23, 2013.
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm362038.htm


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