—#150442

Product

Alaris Pump Module, Model No. 8100 and AIL sensor kits, P/N 147083-102 and P/N 49000221. The Alaris Pump module is a large volume infusion pump offered under the Alaris System. The Alaris Pump module will deliver medication and fluids using IV administration sets for continuous or intermittent delivery through clinically acceptable routes of administration such as intravenous or epidural

FDA product code: FRN — Pump, Infusion
Device class: Class 2
Medical specialty: General Hospital
510(k) numbers: K950419
Affected lot / code info: All products manufactured or serviced in the time period October 2011 through June 2015.

Why it was recalled

During an infusion, a false Air-in-Line (AIL) alarm would cause the infusion to be interrupted.

Root cause (FDA determination)

Component change control

Action the firm took

Carefusion (BD) sent a Medical Device Safety Notification letter dated December 2, 2016, to all affected customers. The letter informed customers that BD has identified an issue with the Alaris Pump module. The letter informs the customers that the firm has received reports of Air-In-Line (AIL) alarms that have occurred when no air is observed in the line. Customers were informed of the issue and of the potential risk involved. The letter informs the customers of the actions for users and additional actions for biomedical engineering. Customers with questions regarding recall related questions were instructed to contact BD Support Center at (888) 562-6018, 7-4pm PT, M-F or email supportcenter@carefusion.com. Customers with adverse event reports are instructed to contact Customer Advocacy at (888) 812-3266, 24 hrs/day, 7days/wk. or email customerfeedback@carefusion.com. For questions regarding this recall call 858-617-2000.

Recalling firm

Firm: CareFusion 303, Inc.
Address: 10020 Pacific Mesa Blvd, San Diego, California 92121-4386

Distribution

Distribution pattern: Nationwide Distribution

Timeline

Recall initiated: 2016-12-02
Posted by FDA: 2017-01-18
Terminated: 2018-07-24
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #150442. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.