BEUDAMED
    FDA Recall Terminated

    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

    Recall: Z-0061-06 · Initiated August 29, 2005

    Recall

    Recall Number
    Z-0061-06
    Event Number
    33250
    Firm
    Baxter Healthcare Corp. Rt.
    FEI Number
    1416980
    Product Code
    LNX
    Status
    Terminated
    Root Cause
    Other
    Initiated
    August 29, 2005
    Posted
    October 15, 2005
    Terminated
    February 6, 2008
    Address
    120 & Wilson Rd, Round Lake, IL, 60073

    Description

    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

    Reason

    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.

    Action

    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.

    Distribution

    Missouri, Massachusetts, Vermont, California and Canada.

    Quantity

    5 units