Recall Z-1640-2008 ยท LHI Set, I.V. Fluid Transfer
Baxter Healthcare Corp.
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.
| Date | Aug 24, 2008 (initiated Mar 28, 2008) |
| Status | Terminated |
| Reason | Software anomaly results in inaccurate information being printed out on the Delivery Report, even though the compounder performed the compounding correctly. |
| Root cause | Software design |
| 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 complet |
| Quantity | 5 units |
| Distribution | Arizona, Minnesota, Wisconsin, Puerto Rico and Canada |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.