FDA Recall Terminated

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.

Recall: Z-1640-2008 · Initiated March 28, 2008

Recall

Recall Number: Z-1640-2008
Event Number: 47441
Firm: Baxter Healthcare Corp. Rt.
FEI Number: 1416980
Product Code: LHI
Status: Terminated
Root Cause: Software design
Initiated: March 28, 2008
Posted: August 24, 2008
Terminated: August 25, 2008
Address: 120 & Wilson Rd, Round Lake, IL, 60073

Description

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.

Distribution

Arizona, Minnesota, Wisconsin, Puerto Rico and Canada

Quantity

5 units