Events

Recall of Device Recall LogixCM Compounder Software

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
    30609
  • Event Risk Class
    Class 2
  • Event Number
    Z-0392-05
  • Event Initiated Date
    2004-12-08
  • Event Date Posted
    2004-12-30
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2005-11-01
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=36209
  • 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
    Set, I.V. Fluid Transfer - Product Code LHI
  • Reason
    A software anomaly in the logix cm software could result in a drug mixture being compounded without one of the ingredients if two drugs have the same indentifier in logix and another order entry program being used with the logix software.
  • Action
    Urgent Device Correction letters dated 12/8/04 were sent to the end users via overnight mail. The accounts were informed of the potential for omission of an ingredient if there are duplicate drug Id''s in the order, and were requested to complete and fax the customer reply form to Baxter at 847-270-5457, indicating if they are currently using Logix-CM software. Upon receipt of the reply form, Baxter will schedule a visit to the facility to examine the base and additive inventory information in their MOS database to confirm that there are no duplicate Drug ID numbers and that this issue has not occurred at the facility. They will also secure the MOS database to ensure that the situation will not be able to occur. Any questions were directed to Baxter Clintec Nutrition, option 1, at 1-800-422-2751.

Device

Device Recall LogixCM Compounder Software
  • Model / Serial
    Software version 2.0.9 for Clintec Compounders
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Maryland, Arizona, Indiana, Ohio, Minnesota, Pennsylvania and internationally to Canada
  • Product Description
    Logix-CM Compounder Software, catalog 2M8400; Baxter Healthcare Corporation, Medication Delivery System, Round Lake, IL 60073
  • Manufacturer
    Baxter Healthcare Corp.

Manufacturer

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