BEUDAMED
    FDA Recall Terminated

    Baxter System 1000 Single Patient Hemodialysis Delivery System; Model SYS1000; all series 1000 instruments labeled as System 1000, AltraTouch 1000, Baxter Tina and Baxter Aurora; Baxter Healthcare Corporation, Deerfield, IL 60015 USA or Baxter Healthcare Corporation, McGaw Park, IL 60085 USA

    Recall: Z-0833-03 · Initiated March 20, 2003

    Recall

    Recall Number
    Z-0833-03
    Event Number
    25818
    Firm
    Baxter Healthcare Corp. Rt
    FEI Number
    1416980
    Product Code
    FKP
    Status
    Terminated
    Root Cause
    Other
    Initiated
    March 20, 2003
    Posted
    May 15, 2003
    Terminated
    January 23, 2004
    Address
    120 & Wilson Rd, Round Lake, IL, 60073

    Description

    Baxter System 1000 Single Patient Hemodialysis Delivery System; Model SYS1000; all series 1000 instruments labeled as System 1000, AltraTouch 1000, Baxter Tina and Baxter Aurora; Baxter Healthcare Corporation, Deerfield, IL 60015 USA or Baxter Healthcare Corporation, McGaw Park, IL 60085 USA

    Reason

    The dialysis treatment may be run without the bicarbonate due to an undetected bicarbonate pump stall following a sodium change.

    Action

    Baxter sent recall letters dated 3/20/03 to the Medical Director and Hemodialysis Chief Technicians via first class mail on 3/20/03. The letters informed the accounts of the potential of running a treatment without bicarbonate due to an undetected bicarbonate pump stall following a sodium change, and provided instructions to change the B-A-alarm limits on the System 1000 Delivery Systems and confirm proper functionality after completing these changes. These changes will prevent undetected acid-only delivery in the event of a sodium level change

    Distribution

    The devices were distributed nationwide and internationally to Baxter subsidiaries in Argentina, Belgium, Bolivia, Brazil, Canada, Chile, China, Ecuador, Egypt, El Salvador, Guatemala, Honduras, Hong Kong, India, Mexico, Philippines, Singapore, South Korea, Thailand, Turkey, United Kingdom, Venezuela and Vietnam.

    Quantity

    25,014 units