BEUDAMED
    FDA Recall Terminated

    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

    Recall: Z-0033-06 · Initiated June 16, 2005

    Recall

    Recall Number
    Z-0033-06
    Event Number
    32449
    Firm
    Baxter Healthcare Corp. Rt.
    FEI Number
    1416980
    Product Code
    NSX
    Status
    Terminated
    Root Cause
    Other
    Initiated
    June 16, 2005
    Posted
    October 8, 2005
    Terminated
    February 6, 2008
    Address
    120 & Wilson Rd, Round Lake, IL, 60073

    Description

    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

    Reason

    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.

    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.

    Distribution

    Missouri, Massachusetts, Vermont, California and Canada.

    Quantity

    5 units