BEUDAMED
    FDA Recall Terminated

    Baxter SPS 550 Single Patient System Hemodialysis Machine; Baxter Healthcare Corporation, Renal Division, 1425 Lake Cook Road, Deerfield, IL 60015

    Recall: Z-0660-03 · Initiated February 20, 2003

    Recall

    Recall Number
    Z-0660-03
    Event Number
    25607
    Firm
    Baxter Healthcare Corp. Rt
    FEI Number
    1416980
    Product Code
    FKP
    Status
    Terminated
    Root Cause
    Other
    Initiated
    February 20, 2003
    Posted
    March 20, 2003
    Terminated
    March 27, 2006
    Address
    120 & Wilson Rd, Round Lake, IL, 60073

    Description

    Baxter SPS 550 Single Patient System Hemodialysis Machine; Baxter Healthcare Corporation, Renal Division, 1425 Lake Cook Road, Deerfield, IL 60015

    Reason

    Excess or insufficient ultrafiltration may occur during manual control of ultrafiltration via adjustment of transmembrane pressure (TMP)

    Action

    Baxter sent Safety Alert letters dated 2/20/03 to the end users, informing them of the possibility of either excess or insufficient ultrafiltration when the operator manually controls ultrafiltration via adjustment of transmembrane pressure. The accounts were informed that turning off the UF controller during fault codes FL-04, FL-07 and FL-08 may affect the ability to safely perform manual ultrafiltration, and that treatment should be discontinued if those three fault codes are displayed. Changes to the instructions for use are in process and will be sent to the end users when completed. Additionally, the Baxter 1550 has a side panel that contains a 16-digit display. Currently, during all ultrafiltration system fault modes the display indicates 'Manual UF Control'. To avoid operator confusion, new software is being developed that will provide a display of 'Discontinue TX' when a FL-04, FL-07 or FL-08 fault code occurs. The SPS 550 does not have the side panel display and does not require the software upgrade.

    Distribution

    Nationwide and internationally to Algeria, AMerican Samoa, Argentina, Aruba, Australia, Barbados, Belgium, Bolivia, Brazil, Brunei, Burma, Canada, Chile, China, Colombia, Croatia, Cyprus, Dominican Republic, Ecuador, Egypt, El Salvador, Yugoslavia, Germany, Ghana, Guam, Guatemala, Honduras, Hong Kong, Hungary, INdia, Indonesia, Israel, Italy, Jamaica, Jordan, Lebanon, Malaysia, Mexico, Nicaragua, Pakistan, Panama, Paraguay, Peru, Philippines, Poland, Romania, Russia, South Korea, Singapore, Slovakia, Slovenia, South Africa, Spain, St. Maarten, Taiwan, Thailand, Tobago, Trinidad, Turkey, United Kingdom, Uruguay, Venezuela and Vietnam.