Events

Recall of Device Recall Logix TPN Software Solution

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
    47441
  • Event Risk Class
    Class 2
  • Event Number
    Z-1640-2008
  • Event Initiated Date
    2008-03-28
  • Event Date Posted
    2008-08-24
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2008-08-25
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=69504
  • 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
    Intravascular Administration Set - Product Code LHI
  • Reason
    Software anomaly results in inaccurate information being printed out on the delivery report, even though the compounder performed the compounding correctly.
  • Action
    Baxter sent the 3/28/08 Urgent Device Correction letter to affected customers, to the attention of the Director of Pharmacy, via first class mail to advise them of the potential inaccuracy of the Delivery Report due to a software anomaly. The accounts were instructed to review each delivery report for accuracy. If the report contains zero actual volumes the user must manually reprint the report. The letter outlined the process for reprinting the Delivery Report. Any questions were directed to the Baxter Nutritional Professional Services at 1-800-422-2751. The accounts were requested complete the enclosed reply form acknowledging receipt and understanding of the letter and dissemination of the information to their staff. A software upgrade will be provided. If you have questions about this letter or you did not receive this letter contact Baxter Nutrition Professional Services at 1-800-422-2751.

Device

Device Recall Logix TPN Software Solution
  • Model / Serial
    Software version 1.0.2 (comprised of Logix OE version 1.0.28 and Logix CM version 3.1.8)
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Arizona, Minnesota, Wisconsin, Puerto Rico and Canada
  • Product Description
    Logix TPN Software Solution, catalog 2M8410, consists of the Logix Order Entry (OE) Installation CD, version 1.0.28 and Logix Compounder Manager (CM) Installation CD, version 3.1.8. The software is included in a number of Baxter's pharmacy compounders. The software assists the pharmacist in management of compounding, creating and authorizing nutritional solutions intended for IV administration.
  • Manufacturer
    Baxter Healthcare Corp.

Manufacturer

Baxter Healthcare Corp.
  • Manufacturer Address
    Baxter Healthcare Corp., Rt. 120 & Wilson Rd, Round Lake IL 60073
  • Source
    USFDA