—#69504

Product

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.

FDA product code: LHI — Set, I.V. Fluid Transfer
Device class: Class 2
Medical specialty: General Hospital
Affected lot / code info: Software version 1.0.2 (comprised of Logix OE version 1.0.28 and Logix CM version 3.1.8)

Why it was recalled

Software anomaly results in inaccurate information being printed out on the Delivery Report, even though the compounder performed the compounding correctly.

Root cause (FDA determination)

Software design

Action the firm took

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.

Recalling firm

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

Distribution

Distribution pattern: Arizona, Minnesota, Wisconsin, Puerto Rico and Canada

Timeline

Recall initiated: 2008-03-28
Posted by FDA: 2008-08-24
Terminated: 2008-08-25
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #69504. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.