—#40109

Product

Baxter''s Patient Care System (BPCS) software, composed of Pharmacy Management - Inpatient - product code 2M5013, Point of Care - product code 2M5014 and Management Reports - product code 2M5015; Baxter Healthcare Corporation, 1 Baxter Parkway, Deerfield, IL 60015, USA, made in Canada

FDA product code: NSX
Affected lot / code info: Software version 4.1-77, 4.0-66 and 3.4-18.24

Why it was recalled

If a pharmacy end user alters the Administration Unit of Measure (AUOM) of an ordered drug, the AUOM will display incorrectly on the Medication Administration Record for the patient, possibly leading to medication errors.

Root cause (FDA determination)

Other

Action the firm took

Urgent Device Correction recall letters dated 6/16/05 were sent to the direct accounts on the same date via first class mail. The letter describes the issue with the Administration Unit of Measure (AUOM), and informed the accounts that changing the AUOM of an ordered drug presents a patient safety issue resulting in a potential for a medication error. The accounts were requested to eliminate or minimize any further AUOM changes until a software upgrade is available. If an AUOM change is required the pharmacy end user must contact the Baxter Patient Care Helpdesk at 1-877-835-2727 prior to any changes being made. A Technical Bulletin was provided with the letter to guide the pharmacy end user through the process of an AUOM change with the aide of a Client Support Specialist.

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: 2005-06-16
Posted by FDA: 2005-10-08
Terminated: 2008-02-06
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #40109. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.