Events

Recall of Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 6)

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

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
    79177
  • Event Risk Class
    Class 2
  • Event Number
    Z-0971-2018
  • Event Initiated Date
    2017-10-06
  • Event Status
    Open, Classified
  • Event Country
    United States
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=161516
  • 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
    Certain infusion pumps may exhibit excessive wear of the pumping mechanism caused by a lack of lubrication, this could affect the occlusion of the tubing and result in over- or under-infusion.
  • Action
    An Urgent Medical Device Correction, dated October 6, 2017, was sent to customers. The letter described the problem, identified the affected device, discussed the hazard involved, and action to be taken. Customers were asked to locate the affected products at their facility. Customers should continue to follow the instructions in document 41394 Rev. A, PREVENTIVE MAINTENANCE, for their entire fleet of pumps. Baxter will inspect affected pumps. To arrange for return of devices that have failed the flow rate accuracy test, contact Baxter Healthcare Medina. If you are a dealer, wholesaler, or distributor/reseller that distributed any product to other facilities, please notify your customers of this Urgent Medical Device Correction. If there are additional questions, customers can contact their Baxter Sales Rep or Baxter Healthcare Medina at 800-356-3454.

Device

Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 6)
  • Model / Serial
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - US, including the District of Columbia, Puerto Rico, and Canada.
  • Product Description
    Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 6) (GTIN 00085412091570); Model Numbers: 35700BAX and 35700ABB. || Intended to be used for the controlled administration of fluids.
  • Manufacturer
    Baxter Healthcare Corporation

Manufacturer

Baxter Healthcare Corporation
  • Manufacturer Address
    Baxter Healthcare Corporation, 711 Park Ave, Medina NY 14103-1036
  • Manufacturer Parent Company (2017)
    Baxter International
  • Source
    USFDA