BEUDAMED
    FDA Recall Terminated

    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

    Recall: Z-0950-2017 · Initiated December 2, 2016

    Recall

    Recall Number
    Z-0950-2017
    Event Number
    75466
    Firm
    CareFusion 303, Inc.
    FEI Number
    2016493
    Product Code
    FRN
    Status
    Terminated
    Root Cause
    Component change control
    Initiated
    December 2, 2016
    Posted
    January 18, 2017
    Terminated
    July 24, 2018
    Address
    10020 Pacific Mesa Blvd, San Diego, CA, 92121-4386

    Description

    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

    Reason

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

    Action

    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 [email protected]. Customers with adverse event reports are instructed to contact Customer Advocacy at (888) 812-3266, 24 hrs/day, 7days/wk. or email [email protected]. For questions regarding this recall call 858-617-2000.

    Distribution

    Nationwide Distribution

    Quantity

    382,635 units