BEUDAMED
    FDA Recall Terminated

    Baxter Renal Software Suite v.3.0 and v.3.1 - Renal Link HD Module; clinical data management software; Baxter Healthcare Corporation, McGaw Park, Illinois 60085.

    Recall: Z-0528-2008 · Initiated November 14, 2007

    Recall

    Recall Number
    Z-0528-2008
    Event Number
    45856
    Firm
    Baxter Healthcare Renal Div
    FEI Number
    3000210122
    Product Code
    KPF
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    November 14, 2007
    Posted
    January 26, 2008
    Terminated
    February 3, 2010
    Address
    1620 Waukegan Rd, Bldg R, Mc Gaw Park, IL, 60085-6730

    Description

    Baxter Renal Software Suite v.3.0 and v.3.1 - Renal Link HD Module; clinical data management software; Baxter Healthcare Corporation, McGaw Park, Illinois 60085.

    Reason

    Pre-Treatment/Post-Treatment Report errors: 1) The Heparin Bolus Value is displayed on Pre and Post Treatment Reports for patients with "No Heparin" orders (RenalSoft v2.0, Renal Software Suite v.3.0 and v.3.1), and 2) Withheld Medications are incorrectly displayed as Administered on the Pre-Treatment report (RenalSoft v.2.0 only).

    Action

    Baxter Healthcare Corporation sent an Urgent Device Correction letter, dated 11/14/07, to all of the affected customers, informing them of the Heparin Bolus and the Withheld Medication issues and provided them with interim mitigation instructions that they should implement while waiting for a software correction. A Baxter representative will contact the customer to schedule the software update when the upgraded software is released. Customers were requested to complete and return the enclosed Customer Reply Form, indicating that they have disseminated the information to their staff, and indicating if they still have RenalSoft software and require an upgrade. Any questions were directed to Baxter Global Technical Services at 1-800-553-6898, option 4. A follow-up letter dated 3/6/08 was sent to the consignees on the same date, informing them that the upgraded RenalSoft Software v.2.0.1 was now available for installation. The consignees were requested to complete and fax back the customer reply form indicating that they received the letter, and were informed that they would be contacted by a Baxter representative to schedule an installation of the software upgrade at no charge.

    Distribution

    Worldwide Distribution-USA including Puerto Rico, and countries of Australia, Austria, Canada, Chile, Denmark, Finland, Greece, Ireland, Italy, Mexico, The Netherlands, New Zealand, Norway, Panama, Portugal, Spain, Sweden and the United Kingdom

    Quantity

    9 units