BEUDAMED
    FDA Recall Terminated

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

    Recall: Z-1693-2017 · Initiated January 26, 2017

    Recall

    Recall Number
    Z-1693-2017
    Event Number
    76364
    Firm
    Baxter Healthcare Corporation
    FEI Number
    1314492
    Product Code
    FRN
    Status
    Terminated
    Root Cause
    Process design
    Initiated
    January 26, 2017
    Terminated
    May 24, 2018
    Address
    711 Park Ave, Medina, NY, 14103-1036

    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.

    Action

    URGENT MEDICAL DEVICE CORRECTION Letters and Reply Forms (dated 1/26/2017) were mailed to customers via USPS first-class mail on 1/26/2017 providing the necessary instructions to customers. For questions, please contact your Baxter sales representative, or Baxter Healthcare Medina at 800-356-3454 (choose option 1) Monday through Friday, between 7:00 am and 7:00 pm ET.

    Distribution

    Natiowide, Puerto Rico and Canada

    Quantity

    Domestic: 14,175 units; Canada: 187 units