Events

Recall of Device Recall Master Drug Library to be used with SIGMA Spectrum 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
    70658
  • Event Risk Class
    Class 2
  • Event Number
    Z-1451-2015
  • Event Initiated Date
    2015-03-02
  • Event Date Posted
    2015-04-16
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2018-05-22
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=134355
  • 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
    Loading/bolus default dose settings in the master drug library and the values shown on the pump during programming may differ. mdl drug dose time in seconds will round to the nearest integer in minutes on the pump dose setup screen (20 sec may show as 1 min on the pump display). the pump will administer drugs as configured. the discrepancy may cause therapy delay or unintended rate of delivery.
  • Action
    The firm, Baxter, sent an "Urgent Device Correction" letter dated 3/05/2015 with MDL Instructions were sent to all affected users via USPS First Class Mail on 3/05/2015. All four (4) limited launch locations with Master Drug Library (MDL) version 8.0 with SIGMA Spectrum Infusion System version 8.0 were notified via phone call on 3/02/2015. The letter describes the product, problem and actions to be taken. Baxter is requesting customers take the following actions: 1. Follow the steps described in Attachment 1 to confirm that this discrepancy is properly corrected. 2. Complete the enclosed 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. --- Baxter sent a follow-up Communication Letter (dated 3/17/2015) to the initial Urgent Device Correction Letter (dated 3/5/2015) to provide additional clarification and instructions to ensure continued mitigation of this discrepancy as users implement the Spectrum infusion System in their facility. The four launch sites received the follow-up letters via hand delivery; remaining customers received the follow-up letter via hand delivery and/or e-mail. If you have additional questions, please contact your Baxter sales representative, Baxter Healthcare Medina at 800-356-3454 (choose option 1) Monday through Friday, during the hours of 7:00 am to 7:00 pm Eastern Time, or The Center for One Baxter at 800-422-9837, Monday through Friday during the hours of 8:00 am to 5:00 pm Central Time.

Device

Device Recall Master Drug Library to be used with SIGMA Spectrum Infusion Pump
  • Model / Serial
    Software version 8.0, Product Code 35723V080
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution: US Distribution to states of: CA, CT, FL, IA, IL, IN, LA, MA, MD, MI, MN, MO, NC, NE, NH, NY, SD, TX, UT, WV, including Puerto Rico and country of: Canada.
  • Product Description
    Master Drug Library Software version 8.0, Product Code 35723V080, to be used with SIGMA Spectrum Infusion System (Pump) version 8.0, Product Code 35700BAX2 || The SIGMA Spectrum Infusion Pump with Master Drug Library (MDL) is intended to be used for the controlled administration of fluids.
  • Manufacturer
    Baxter Healthcare Corp

Manufacturer

Baxter Healthcare Corp
  • Manufacturer Address
    Baxter Healthcare Corp, 1 Baxter Pkwy # Df6-3w, Deerfield IL 60015-4625
  • Manufacturer Parent Company (2017)
    Baxter International
  • Source
    USFDA