Events

Recall of Device Recall Baxter 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 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
    76364
  • Event Risk Class
    Class 2
  • Event Number
    Z-1693-2017
  • Event Initiated Date
    2017-01-26
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2018-05-24
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=152976
  • 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
    Sigma spectrum infusion pumps with master drug library, software v8.00.02 contains an anomaly that may cause a sharp watchdog timeout error message. specifically, the software anomaly causes the error message only under conditions in which a message is being written to the spectrum infusion pumps event history log (ehl), and the length of that message exactly matches the size of the available memory at the end of a memory sector. for this reason, the issue is significantly more likely to manifest when poor network maintenance results in high volumes of messages being written to the ehl.
  • Action
    URGENT MEDICAL DEVICE CORRECTION Letters and Reply Forms (dated 1/26/2017) were mailed to customers via USPS first-class mail on 1/26/2017 providing the necessary instructions to customers. For questions, please contact your Baxter sales representative, or Baxter Healthcare Medina at 800-356-3454 (choose option 1) Monday through Friday, between 7:00 am and 7:00 pm ET.

Device

Device Recall Baxter SIGMA Spectrum Infusion Pump with Master Drug Library
  • Model / Serial
    14,362 Serial Numbers (please contact CDRH for list of affected Serial Numbers).
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Natiowide, Puerto Rico and Canada
  • Product Description
    Baxter SIGMA Spectrum Infusion Pump with Master Drug Library, Model #/Product Code 35700BAX2
  • 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