BEUDAMED
    FDA Recall Terminated

    Alaris Pump Module Model 8100 (formerly Medley Pump Module) Subsequent Product Code: FPA. The Pump module is intended for facilities that utilize infusion for the delivery of fluids, medications, blood, and blood products using continuous or intermittent delivery through clinically acceptable routes of administration; such as, intravenous (IV), intra-arterial (IA),subcutaneous, epidural, enteral, or irrigation of fluid spaces. The Pump module is indicated for use on adults, pediatrics, and neonates.

    Recall: Z-2205-2012 · Initiated June 15, 2012

    Recall

    Recall Number
    Z-2205-2012
    Event Number
    62642
    Firm
    CareFusion 303, Inc.
    FEI Number
    2016493
    Product Code
    FRN
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    June 15, 2012
    Posted
    August 17, 2012
    Terminated
    May 13, 2014
    Address
    10020 Pacific Mesa Blvd, San Diego, CA, 92121-4386

    Description

    Alaris Pump Module Model 8100 (formerly Medley Pump Module) Subsequent Product Code: FPA. The Pump module is intended for facilities that utilize infusion for the delivery of fluids, medications, blood, and blood products using continuous or intermittent delivery through clinically acceptable routes of administration; such as, intravenous (IV), intra-arterial (IA),subcutaneous, epidural, enteral, or irrigation of fluid spaces. The Pump module is indicated for use on adults, pediatrics, and neonates.

    Reason

    The recall was initiated because Carefusion has identified a potential risk associated with the Alaris Pump module model 8100. The pump module door keypad overlay may separate from the keypad assembly

    Action

    CareFusion sent an "URGENT: MEDICAL DEVICE RECALL NOTIFICATION" letter dated July 20, 2012. The letter identified the product, problem, and actions to be taken by the customers. The potential risk identified in the letter was that when the pump module door keypad overlay has delaminated (loose, peeled away or separated from the door assembly) this could cause a potential for fluid ingress which could lead to a keypad malfunction causing termination of infusion with alarm. Termination of infusion could result in serious injury or death. Customers were informed that CareFusion will contact their facility with in 60 days of receiving the notification to schedule a visit to replace the door assembly of their affected pump module. Customers with recall related questions were instructed to contact CareFusion Support Center at (888) 562-6018. Customers with adverse event reports questions were instructed to contact Customer advocacy at (800) 854-7128, option 1, option 1, option 3 or e-mail at customer feedback @carefusion.com. Customers with technical questions were instructed to contact technical support at (888) 812-3229. Customers were instructed to promptly complete and return the enclosed Customer Response Card to expedite the corrective action process.

    Distribution

    Worldwide Distribution-USA (nationwide) and the countries of Australia, European Union, and South Africa.

    Quantity

    43,862 units total (40,780 units in the US)