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

FDA device recall Z-0392-05 · posted 2004-12-30 · Terminated

Recall details

Recalling firm

Baxter Healthcare Corp.

Reason for recall

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 taken

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.

Root cause

Other

Status

Terminated

Product code

LHI

Quantity affected

12 units

Distribution

Maryland, Arizona, Indiana, Ohio, Minnesota, Pennsylvania and internationally to Canada

Date initiated

2004-12-08

Date posted

2004-12-30

Date terminated

2005-11-01

Location

Round Lake, IL