Class I CareFusion Alaris Syringe Pump Alarm

Company: CareFusion 303, Inc.
Date of Enforcement Report 7/2/2015
Class l:

PRODUCT

A syringe pump is a small infusion pump that delivers fluids, such as nutrients and medications, into a patient?s body in controlled amounts. They are widely used in clinical settings such as hospitals, nursing homes, and in the home..

REASON
An error in the syringe pump triggers a visual and audible alarm and causes the pump to stop supplying the infusion to the patient. Even when the user clears the error code 351.6740, the syringe pump does not respond to key presses until the product is detached and reattached to the PC unit used to program, monitor and provide power to the syringe pump. Failure of syringe module may result in a delay or interruption of therapy and can lead to serious patient injury or death.

CareFusion has received 108 reports of the issue occurring. There have been no reports of permanent injury or death…

RECALLING FIRM/MANUFACTURER
CareFusion 303, Inc., San Diego CA on 7/2/2015.

VOLUME OF PRODUCT IN COMMERCE
6,458

DISTRIBUTION
US

FDA District: Los Angeles

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About the author

Amy enjoys researching and writing about developments in medical technology and how that intersects with US law. She received her J.D. from the University of Florida Levin College of Law in 2020 and now works as a Regulatory Associate for SoftwareCPR®, a general-purpose regulatory consulting firm that is recognized globally for their expertise with standards and national regulations pertaining to medical device, mobile medical app, and HealthIT software.

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