Events

Recall of Device Recall SIGMA SPECTRUM Volumetric Infusion Pump

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
    67523
  • Event Risk Class
    Class 1
  • Event Number
    Z-1484-2014
  • Event Initiated Date
    2014-02-07
  • Event Date Posted
    2014-04-25
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-05-25
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=125668
  • 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 has issued an urgent device correction for the sigma spectrum volumetric infusion pump with master drug library due to repeated system error 322 occurrences.
  • Action
    On February 7, 2014, Baxter Healthcare Corporation distributed Urgent Device Correction notices and Customer Reply Forms to their customers via first-class mail. Affected customers are instructed to contact Baxter Healthcare Corporation at 1-800-356-3454 (choose option 1) Monday through Friday during the hours of 7:00 am to 7:00 pm Eastern Time. Baxter technicians would determine if an adjustment or repair is necessary. Customers are asked to complete the attached Customer Reply Form and return it to Baxter either by faxing to 1-224-270-5457 or e-mailing a scanned copy to fca@baxter.com.

Device

Device Recall SIGMA SPECTRUM Volumetric Infusion Pump
  • Model / Serial
    Product Codes: 35700BAX, 35700ABB
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA Nationwide including PR and the country of Canada.
  • Product Description
    SIGMA SPECTRUM Volumetric Infusion Pump with Master Drug Library || Product Usage: Sigma Spectrum Volumetric Infusion Pumps with Master Drug Library are intended to be used for the controlled administration of intravenous fluids. These fluids may include pharmaceutical drugs, blood, blood products and mixtures of required patient therapy.
  • 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