BEUDAMED
    FDA Enforcement Class II Terminated

    Baxter SIGMA Spectrum Infusion Pump with Master Drug Library, Model #/Product Code 35700BAX2

    Recall: Z-1693-2017 · Reported April 5, 2017

    Enforcement

    Recall Number
    Z-1693-2017
    Event ID
    76364
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Baxter Healthcare Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    April 5, 2017
    Initiation Date
    January 26, 2017
    Classification Date
    March 29, 2017
    Termination Date
    May 24, 2018
    Address
    711 Park Ave, Medina, NY, 14103-1036, United States

    Description

    Baxter SIGMA Spectrum Infusion Pump with Master Drug Library, Model #/Product Code 35700BAX2

    Reason

    SIGMA Spectrum Infusion Pumps with Master Drug Library, Software V8.00.02 contains an anomaly that may cause a Sharp Watchdog Timeout error message. Specifically, the software anomaly causes the error message only under conditions in which a message is being written to the Spectrum Infusion Pumps Event History Log (EHL), and the length of that message exactly matches the size of the available memory at the end of a memory sector. For this reason, the issue is significantly more likely to manifest when poor network maintenance results in high volumes of messages being written to the EHL.

    Code Info

    14,362 Serial Numbers (please contact CDRH for list of affected Serial Numbers).

    Distribution

    Natiowide, Puerto Rico and Canada

    Quantity

    Domestic: 14,175 units; Canada: 187 units