Events

Recall of Device Recall Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 6 and Version 8)

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
    80014
  • Event Risk Class
    Class 2
  • Event Number
    Z-2112-2018
  • Event Initiated Date
    2018-05-08
  • 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=164214
  • 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
    The firm will be updating the instructions for use for the product. current ifus instruct users to lower the primary bag 20 inches below the secondary bag using a hanger when performing a secondary infusion. however, the firm supplies 12.5-inch hangers with the baxter disposable secondary sets.
  • Action
    On May 8, 2018, Baxter issued a Medical Device Correction letter to its customers. Customers were advised of the issue and instructed to do the following: 1. The SIGMA SPECTRUM Infusion Pumps can continue to be safely used with the Baxter-provided 12.5-inch hanger. 2. The updated Instructions for Use will be made available by May 31, 2018. At that time, you may access the updated IFU online at the Baxter Global Technical E-Service Center at URL: https://service.baxter.com/tsportal/#/login. For additional questions and concerns about this issue please contact Baxter Healthcare Medina at 800-356-3454, Option 1, between the hours of 7:00 am and 7:00 pm Eastern Time. 3. If you purchased this product directly from Baxter, complete the enclosed Baxter customer reply form and return it to Baxter by faxing it to 224-270-5457 or scanning and e-mailing it to fca@baxter.com, even if you do not have any inventory. Returning the Baxter customer reply form promptly will prevent you from receiving repeat notices. 4. If you purchased this product form a distributor, please note that the Baxter customer reply form is not applicable. If a reply form is provided by your distributor or wholesaler, please return it to the supplier according to their instructions. 5. If you distribute this product to other facilities or departments within your institution, please forward a copy of this communication to them. 6. If you are a dealer, wholesaler, distributor/reseller, or original equipment manufacturer (OEM) that distributed any affected product to other facilities, please notify your customers of this Medical Device Correction in accordance with your customary procedures.

Device

Device Recall Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 6 and Versio...
  • Model / Serial
    All serial numbers manufactured from 11/1/2005 to 4/22/2013, with release dates 1/1/2005 and forward.
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - US Nationwide and the country of Canada.
  • Product Description
    Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 6), infusion pump, 35700BAX and 35700ABB || Product Usage: || The Baxter SIGMA Spectrum Infusion Pump with Master Drug Library is intended to be used for the controlled administration of fluids. These fluids may include pharmaceutical drugs, blood, blood products and mixture of required patient therapy. The intended routes of administration consist of the following clinically accepted routes: intravenous, arterial, subcutaneous, intrathecal, epidural or irrigation of fluid space. Spectrum Infusion Pump is intended to be used in conjunction with legally marketed intravenous administration sets and medications provided by the user. The Spectrum and Spectrum with Master Drug Library is suitable for many user facility applications such as but not limited to hospitals, outpatient care areas, homecare and ambulatory care services. Spectrum and Spectrum with Master Drug Library is intended to reduce operator interaction through automated programming thereby helping to reduce errors associated with complex device programming. Parameter programming requires trained healthcare professional confirmation of limits and drug therapy to the physicians directive.
  • 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