BEUDAMED
    FDA Enforcement Class II Terminated

    Master Drug Library Software version 8.0, Product Code 35723V080, to be used with SIGMA Spectrum Infusion System (Pump) version 8.0, Product Code 35700BAX2 The SIGMA Spectrum Infusion Pump with Master Drug Library (MDL) is intended to be used for the controlled administration of fluids.

    Recall: Z-1451-2015 · Reported April 22, 2015

    Enforcement

    Recall Number
    Z-1451-2015
    Event ID
    70658
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Baxter Healthcare Corp
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Telephone
    Report Date
    April 22, 2015
    Initiation Date
    March 2, 2015
    Classification Date
    April 16, 2015
    Termination Date
    May 22, 2018
    Address
    1 Baxter Pkwy # Df6-3w, N/A, Deerfield, IL, 60015-4625, United States

    Description

    Master Drug Library Software version 8.0, Product Code 35723V080, to be used with SIGMA Spectrum Infusion System (Pump) version 8.0, Product Code 35700BAX2 The SIGMA Spectrum Infusion Pump with Master Drug Library (MDL) is intended to be used for the controlled administration of fluids.

    Reason

    Loading/Bolus default dose settings in the Master Drug Library and the values shown on the pump during programming may differ. MDL drug dose time in seconds will round to the nearest integer in minutes on the pump dose setup screen (20 sec may show as 1 min on the pump display). The pump will administer drugs as configured. The discrepancy may cause therapy delay or unintended rate of delivery.

    Code Info

    Software version 8.0, Product Code 35723V080

    Distribution

    Worldwide Distribution: US Distribution to states of: CA, CT, FL, IA, IL, IN, LA, MA, MD, MI, MN, MO, NC, NE, NH, NY, SD, TX, UT, WV, including Puerto Rico and country of: Canada.

    Quantity

    58 MDLs