—#41544

Product

Baxter''s Patient Care System (BPCS) software, Pharmacy Management - Inpatient - product code 2M5013 and Point of Care - product code 2M5014; Baxter Healthcare Corporation, 1 Baxter Parkway, Deerfield, IL 60015, USA, made in Canada

FDA product code: LNX
Affected lot / code info: all units of software versions 4.0 (66) and 4.1 (77)

Why it was recalled

If an administrative user modifies any of the seven pre-defined Monitoring Parameters when they are attached to a medication in the drug file, a Point of Care end user will be unable to enter monitoring parameter results on the handheld.

Root cause (FDA determination)

Other

Action the firm took

Urgent Device Correction recall letters dated 8/29/05 were sent to the direct accounts on the same date via first class mail. The letter describes the issue with the modification or creation of a Monitoring Parameter, and informed the accounts that modifying the Monitoring Parameters could result in a potential for a patient receiving an incorrect medication or an incorrect medication dosage. The accounts were advised that administrative end users should never modify the seven pre-defined Monitoring Parameters or create new Monitoring Parameters.

Recalling firm

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

Distribution

Distribution pattern: Missouri, Massachusetts, Vermont, California and Canada.

Timeline

Recall initiated: 2005-08-29
Posted by FDA: 2005-10-15
Terminated: 2008-02-06
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #41544. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.