BEUDAMED
    FDA Recall Terminated

    SIGMA SPECTRUM Infusion Pump with Master Drug Library. Intended to be used for the controlled administration of intravenous fluids.

    Recall: Z-0197-2014 · Initiated June 10, 2013

    Recall

    Recall Number
    Z-0197-2014
    Event Number
    66120
    Firm
    Baxter Healthcare Corp.
    FEI Number
    1417572
    Product Code
    FRN
    Status
    Terminated
    Root Cause
    Process design
    Initiated
    June 10, 2013
    Posted
    November 8, 2013
    Terminated
    April 20, 2017
    Address
    1 Baxter Pkwy, Deerfield, IL, 60015-4625

    Description

    SIGMA SPECTRUM Infusion Pump with Master Drug Library. Intended to be used for the controlled administration of intravenous fluids.

    Reason

    Baxter Healthcare Corporation issued an Urgent Device Correction for the SIGMA SPECTRUM Infusion Pump with Master Drug Drug Library due to reports of upstream occlusion alarms and air-in-line alarms occurring during infusions.

    Action

    On June 10, 2013 Baxter Healthcare Corporation issued an Urgent Device Correction for the SIGMA SPECTRUM Infusion Pump with Master Drug Library. The notices were dated June 5, 2013 and were distributed via first class mail. Until further information is provided, users should continue to follow the SIGMA SPECTRUM Infusion Pump Operator's Manual, which identifies a number of environmental and clinical usage factors that contribute to upstream occlusion and air-in-line alarms. For high-risk patients, consider having additional devices as backup. If the biomedical engineer finds that the sensor is not functioning properly, contact Baxter Healthcare at 800-356-3454 (choose option 1). For clinical questions, please contact Medical Information Services at Baxter at 800-933-0303, Monday through Friday 8:00am to 5:00 pm Central Time.

    Distribution

    Worldwide Distribution-USA including Puerto Rico and Canada.

    Quantity

    273,835 units