—#36209

Product

Logix-CM Compounder Software, catalog 2M8400; Baxter Healthcare Corporation, Medication Delivery System, Round Lake, IL 60073

FDA product code: LHI — Set, I.V. Fluid Transfer
Device class: Class 2
Medical specialty: General Hospital
Affected lot / code info: Software version 2.0.9 for Clintec Compounders

Why it was recalled

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.

Root cause (FDA determination)

Other

Action the firm took

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.

Recalling firm

Firm: Baxter Healthcare Corp. Rt.
Address: 120 & Wilson Rd, Round Lake, Illinois 60073

Distribution

Distribution pattern: Maryland, Arizona, Indiana, Ohio, Minnesota, Pennsylvania and internationally to Canada

Timeline

Recall initiated: 2004-12-08
Posted by FDA: 2004-12-30
Terminated: 2005-11-01
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #36209. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.