Events

Recall of Device Recall SIGMA SPECTRUM Infusion Pump with Master Drug Library

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Baxter Healthcare Corp..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    66120
  • Event Risk Class
    Class 2
  • Event Number
    Z-0197-2014
  • Event Initiated Date
    2013-06-10
  • Event Date Posted
    2013-11-08
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-04-20
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=121520
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Pump, infusion - Product Code FRN
  • 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.

Device

Device Recall SIGMA SPECTRUM Infusion Pump with Master Drug Library
  • Model / Serial
    Product Code: 35700BAX, 35700ABB Serial Numbers: All
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution-USA including Puerto Rico and Canada.
  • Product Description
    SIGMA SPECTRUM Infusion Pump with Master Drug Library. || Intended to be used for the controlled administration of intravenous fluids.
  • Manufacturer
    Baxter Healthcare Corp.

Manufacturer

Baxter Healthcare Corp.
  • Manufacturer Address
    Baxter Healthcare Corp., 1 Baxter Pkwy, Deerfield IL 60015-4625
  • Manufacturer Parent Company (2017)
    Baxter International
  • Source
    USFDA