Baxter Healthcare Renal Div Baxter Healthcare Corporation, RenalSoft Observational Study v.2.0 - HD Module, PD Module and Medical Record Module; clinical data management software; Baxter Healthcare Corporation, McGaw Park, Illinois 60085 Recall

Check Your Product

According to the U.S. Food and Drug Administration (FDA)

Reason for Recall

As stated by FDA

Software Error: There are software discrepancies that may increase the possibility of a medication error if the dialysis clinic software is used to track, record, or coordinate the administration of medications.

Recommended Action

Per FDA guidance

Baxter sent Urgent Device Correction letters dated 3/29/06 to those customers who had their RenalSoft and Renal Software Suite software configured with the affected modules. The letters indicated in a table which software anomalies were associated with the affected software modules in each software version. A description of each anomaly was provided, along with interim actions to take to mitigate the anomaly until the new software version RenalSoft V.2.0.x can be issued. Individual customer training will be performed at each facility for those issues identified in the letter specific to their software version. At that time the mitigation provided in the letter will be reviewed with the customer.