BEUDAMED
    FDA Recall Terminated

    Baxter Arena Hemodialysis Systems, product codes ARENADPX, ARENASP, ARENADPP, ARENASPX; Baxter Healthcare Corporation, Renal Division, McGaw Park, IL 60085

    Recall: Z-1395-05 · Initiated June 14, 2005

    Recall

    Recall Number
    Z-1395-05
    Event Number
    32322
    Firm
    Baxter Healthcare Renal Div
    FEI Number
    3000210122
    Product Code
    KDI
    Status
    Terminated
    Root Cause
    Other
    Initiated
    June 14, 2005
    Posted
    August 24, 2005
    Terminated
    February 26, 2008
    Address
    1620 Waukegan Rd, Bldg R, Mc Gaw Park, IL, 60085-6730

    Description

    Baxter Arena Hemodialysis Systems, product codes ARENADPX, ARENASP, ARENADPP, ARENASPX; Baxter Healthcare Corporation, Renal Division, McGaw Park, IL 60085

    Reason

    Operator's Manuals addenda are being issued to provide correct information concerning the correct syringe size to use for heparin infusion, the use of chemical disinfectants in the System 1000, TMP Advise, and Bicarbonate Value calculations.

    Action

    Baxter sent Important Product Information letters dated 6/14/05 to all System 1000 and Arena Hemodialysis customers, to the attention of the Hemodialysis Administrator, via first class mail. Enclosed with the letter were copies of addenda to the Operator''s Manual for both the System 1000 and Arena instruments. The letter informed the accounts of the following problems: a) Improper Syringe Size - it is important to use the correct syringe size for heparin infusion to avoid improper infusion of heparin. The warning 'Ensure the instrument is properly configured for the type and size of heparin pump syringe being installed.' was added to the manual under the Priming the Dialyzer and Blood Lines section of Operation. b) Disinfection Infusion Monitor (System 1000 only) - Procedural steps have been added to the System 1000 manual to confirm the level in the disinfectant bottle prior to and after chemical disinfection to ensure that disinfection fluid has been utilized during the disinfection cycle. c) TMP Advise - the 'TMP Alarm in Dialyzer Mode' section in both the System 1000 and Arena manuals has been removed. d) Bicarbonate Value - the Dialysate Preparation section of the manual was revised to clarify the bicarbonate display of the System 1000 and Arena instruments. Any questions were directed to Baxter Global Technical Services at 1-800-553-6898.

    Distribution

    Nationwide and internationally to Argentina, Australia, Belgium, Brazil, Canada, Chile, China, Colombia, India, Indonesia, Korea, Mexico, Peru, Philippines, Singapore, Spain, Switzerland, Taiwan, Thailand and Turkey.

    Quantity

    623 units