Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-0033-06

Baxter''s Patient Care System (BPCS) software, composed of Pharmacy Management - Inpatient - product code...

Baxter Healthcare Corporation / initiated 2005-06-16 / Terminated

Baxter Healthcare Corp. began a recall of Baxter''s Patient Care System (BPCS) software, composed of Pharmacy Management - Inpatient - product code 2M5013, Point of Care - product code 2M5014 and... on . The reason FDA records is "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". As of , the recall status on record is Terminated.

Recall record

Recall number
Z-0033-06
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Baxter Healthcare Corporation
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
Product code
NSX
Reason for recall
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.
FDA root cause
Other
Action
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.
Quantity in commerce
5 units
Distribution
Missouri, Massachusetts, Vermont, California and Canada.
Product codes and lots
Software version 4.1-77, 4.0-66 and 3.4-18.24