BEUDAMED
    FDA Recall Terminated

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

    Recall: Z-0833-06 · Initiated March 29, 2006

    Recall

    Recall Number
    Z-0833-06
    Event Number
    34943
    Firm
    Baxter Healthcare Renal Div
    FEI Number
    3000210122
    Product Code
    KPF
    Status
    Terminated
    Root Cause
    Other
    Initiated
    March 29, 2006
    Posted
    May 3, 2006
    Terminated
    February 26, 2008
    Address
    1620 Waukegan Rd, Bldg R, Mc Gaw Park, IL, 60085-6730

    Description

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

    Reason

    Software Error: There are software discrepancies that may increase the possibility of a medication error if the dialysis clinic software is used to track, record, or coordinate the administration of medications.

    Action

    Baxter sent Urgent Device Correction letters dated 3/29/06 to those customers who had their RenalSoft and Renal Software Suite software configured with the affected modules. The letters indicated in a table which software anomalies were associated with the affected software modules in each software version. A description of each anomaly was provided, along with interim actions to take to mitigate the anomaly until the new software version RenalSoft V.2.0.x can be issued. Individual customer training will be performed at each facility for those issues identified in the letter specific to their software version. At that time the mitigation provided in the letter will be reviewed with the customer.

    Distribution

    Nationwide (Alabama, Arizona, California, Colorado, Connecticut, Illinois, Iowa, Kansas, Maryland, Massachusetts, Michigan, Minnesota, Missouri, New York, Pennsylvania, South Dakota,Texas and Wisconsin); and internationally to Australia, Austria, Canada, Denmark, Finland, Greece, Ireland, Italy, the Netherlands, Norway, Portugal, Spain, Sweden and the United Kingdom.

    Quantity

    6 - U.S., 44 - International