BEUDAMED
    FDA Recall Terminated

    System 1000 family of Hemodialysis Instruments, including the System 1000, TINA, AURORA and ARENA; Baxter Healthcare Corporation, Deerfield, IL 60015 U.S.A.

    Recall: Z-0347-06 · Initiated November 18, 2005

    Recall

    Recall Number
    Z-0347-06
    Event Number
    34043
    Firm
    Baxter Healthcare Renal Div
    FEI Number
    3000210122
    Product Code
    KDI
    Status
    Terminated
    Root Cause
    Other
    Initiated
    November 18, 2005
    Posted
    January 6, 2006
    Terminated
    March 4, 2008
    Address
    1620 Waukegan Rd, Bldg R, Mc Gaw Park, IL, 60085-6730

    Description

    System 1000 family of Hemodialysis Instruments, including the System 1000, TINA, AURORA and ARENA; Baxter Healthcare Corporation, Deerfield, IL 60015 U.S.A.

    Reason

    Potential for fluid or air to be passed through the venous line clamp if the tubing is not centered in the clamp and extends beyond the edge of the clamp's pinch zone. This could result in an air emboli condition.

    Action

    Baxter sent Urgent Device Correction letters dated 11/18/05 to all System 1000, TINA, Aurora and Arena Hemodilaysis Instrument customers via first class mail on the same date, to the attention of the Hemodialysis Administrator. The letters informed the accounts that the potential exists for fluid or air to be passed through the venouus line clamp that could result in an air emboli condition. This condition can occur when the tubing is not centered on the clamp and extends beyond the edge of the clamp''s pinch zone. Baxter will make arrangements to upgrade the instruments with either a linear or rotary venous line clamp upgrade as soons as they become available within the next three months. The letters included copies of a diagram showing the correct and incorrect placement of the tubing in the clamp, and a Technical Service Bulletin that provided an adjustment procedure to perform an interim correction to the linear line clamp configuration prior to the upgrade. Any questions regarding the execution of this procedure were directed to Baxter Global Technical Services at 1-800-553-6898.

    Distribution

    Nationwide and internationally to Canada, Korea, Hong Kong, Shanghai, Jamaica, Philippines, United Kingdom, Denmark, India, Belgium, Mexico, Italy, Austria, Sweden, Ecuador, Argentina, Brazil, Chile, Colombia, Peru, Turkey and Australia.

    Quantity

    29,173 machines