BEUDAMED
    FDA Recall Terminated

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

    Recall: Z-0766-06 · Initiated February 24, 2006

    Recall

    Recall Number
    Z-0766-06
    Event Number
    34645
    Firm
    Baxter Healthcare Renal Div
    FEI Number
    3000210122
    Product Code
    FKP
    Status
    Terminated
    Root Cause
    Other
    Initiated
    February 24, 2006
    Posted
    April 18, 2006
    Terminated
    October 28, 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 Altratouch; Baxter Healthcare Corporation, Deerfield, IL 60015 U.S.A.

    Reason

    The older style 'Through Hardware' Dialysate Monitoring Manifolds and 'Noryl' Ultra Filtration Removal Regulators may become cracked due to mechanical and thermal stress. If either of these parts become cracked during patient treatment, there is the potential for an ultrafiltration error to occur, which can result in excessive removal of fluid from the patient.

    Action

    Baxter sent Urgent Device Correction letters dated 02/24/06 to all System 1000, TINA, Altratouch and Aurora Hemodialysis 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 for the older style 'Through Hardware' Dialysate Monitoring Manifolds and 'Noryl' Ultra Filtration Removal Regulators to become cracked due to mechanical and thermal stress. Color photographs of the old style and new style components were included in the letter. The accounts were informed that if the cracking occurs during patient treatment, the potential exists for an ultra filtration error to occur, which can result in excessive removal of fluid from the patient. Baxter provided a chart to determine which upgrade kit is required for each unit, based on the serial number involved. The accounts were requested to complete the enclosed Action Completion Response form, indicating the instrument serial number and which parts are needed for each machine at the site, and fax the sheet to 1-727-544-3025. Upon receipt of the Action Completion Reply form, a Baxter Field Service Engineer will call the account to schedule the upgrades. Any technical questions were directed to Baxter Global Technical Services at 1-800-553-6898, prompt 3, option 2, choice 1.

    Distribution

    Nationwide including Puerto Rico, and internationally to Algeria, Austria, Bahrain, Belgium, Bulgaria, Croatia, Czech Republic, Denmark, Egypt, Finland, France, Germany, Ireland, Israel, Italy, Jordan, Lebanon, Morocco, the Netherlands, Nigeria, Oman, Poland, Romania, Russia, Slovakia, South Africa, Spain, Sweden, Switzerland, Tunisia, UAE, UK, Turkey, Colombia, Dominican Republic, Trinidad, Jamaica, St. Croix, Brazil, Peru, Ecuador, Australia, Argentina, Paraguay, Uruguay, China, Korea, Taiwan, Philippines, India, Singapore, Malaysia, Thailand, Indonesia and Canada.

    Quantity

    14,917 units