ClearanceBrief
Recall Z-0033-06 ยท NSX

Baxter Healthcare Corp.

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

DateOct 8, 2005 (initiated Jun 16, 2005)
StatusTerminated
ReasonIf 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 causeOther
ActionUrgent 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 an
Quantity5 units
DistributionMissouri, Massachusetts, Vermont, California and Canada.
FDA recordOpen on fda.gov

510(k) clearances named in this recall

This recall record lists no 510(k) number.