BEUDAMED
    FDA Recall Terminated

    System 1000 family of Hemodialysis Instruments, including the System 1000, Arena, 1550, BM11, BM25 and Meridian; Baxter Healthcare Corporation, Deerfield, IL 60015 U.S.A.

    Recall: Z-0367-05 · Initiated December 14, 2004

    Recall

    Recall Number
    Z-0367-05
    Event Number
    30507
    Firm
    Baxter Healthcare Renal Div
    FEI Number
    3000210122
    Product Code
    FII
    Status
    Terminated
    Root Cause
    Other
    Initiated
    December 14, 2004
    Posted
    December 24, 2004
    Terminated
    February 26, 2008
    Address
    1620 Waukegan Rd, Bldg R, Mc Gaw Park, IL, 60085-6730

    Description

    System 1000 family of Hemodialysis Instruments, including the System 1000, Arena, 1550, BM11, BM25 and Meridian; Baxter Healthcare Corporation, Deerfield, IL 60015 U.S.A.

    Reason

    Air bubbles have been observed in the tubing sets past the air detector of the instrument with no alarms. Air bubbles in the circuit can cause an air embolism.

    Action

    An Urgent Device Correction letter dated 12/14/04 was sent along with a reply form and addenda to operator''s manuals to all Baxter customers who have purchased hemodialysis hardware. The letter informed the accounts of reports of air bubbles observed in the tubing sets past the air detector without an alarm alerting the operator of potential air in the tubing. A review of the reports revealed misuse, including failure to follow generally observed hemodialysis practices. Baxter updated their Hemodialysis Operator''s Manuals and Training Guides to clarify instructions and add caution and warning statements to address the possibility of introducing air in the extracorporeal circuit and to clarify methods for clearing air from the circuit. The accounts were requested to review the attached addendum that applies to the instruments used in their facility against the pertinent sections of their Operator''s Manual. If their Operator''s Manual does not match the addendum, they were instructed to order a new manual using the enclosed response form. Any questions were directed to Baxter''s Global Technical Services at 1-800-553-6898.

    Distribution

    This action covers Baxter''s complete line of hemodialysis hardware, which was distributed nationwide, including Puerto Rico, and internationally to Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Chile, China, Denmark, Ecuador, Finland, France, Republic of Georgia, Greece, Guatemala, Honduras, Hong Kong, India, Indonesia, Ireland, Israel, Italy, Korea, Lebanon, Morocco, Malaysia, Netherlands, Oman, Panama, Peru, Philippines, Poland, Palestine, Romania, Russia, Saudia Arabia, Singapore, Slovakia, Spain, Sweden, Taiwan, Thailand, Tunisia, Turkey and the United Kingdom.