BEUDAMED
    FDA Recall Terminated

    Accura System for Blood Filtration, product codes 5M5660 and ACCURA01 (international); a hemofiltration system; Baxter Healthcare Corporation, Renal Division, McGaw Park, IL 60085, manufactured in Germany

    Recall: Z-1380-05 · Initiated July 13, 2005

    Recall

    Recall Number
    Z-1380-05
    Event Number
    32631
    Firm
    Baxter Healthcare Renal Div
    FEI Number
    3000210122
    Product Code
    KDI
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    July 13, 2005
    Posted
    August 18, 2005
    Terminated
    October 29, 2008
    Address
    1620 Waukegan Rd, Bldg R, Mc Gaw Park, IL, 60085-6730

    Description

    Accura System for Blood Filtration, product codes 5M5660 and ACCURA01 (international); a hemofiltration system; Baxter Healthcare Corporation, Renal Division, McGaw Park, IL 60085, manufactured in Germany

    Reason

    In the event therapy is terminated, as part of routine instrument programming or therapy maintenance, the Accura instrument may experience difficulty in performing a successful self-test (failure) upon an immediate attempt to restart therapy

    Action

    Baxter sent Important Product Information letters dated 7/13/05 to all Accura device customers, to the attention of the Director of Nursing, via first class mail. The letter informed the accounts of the on-going investigation into the potential self-test failure associated with the Accura instrument, and provided the customers with steps to follow if they encounter failed instrument self-tests. These guidance steps include: 1) Place the instrument into 'stand-by' mode. Generally, 15 minutes in 'stand-by' mode is sufficient to allow successful instrument self-test procedures. Enter 'stand-by' mode by turning off the power by using the upper power switch, or by selecting 'Accura off' from the user interface. Avoid selecting 'Next treatment' as this immediately puts the Accura into self-test mode. 2) After 15 minute, turn the power on. 3) After successful completion of self-test, resume therapy per the Accura Operator's Manual. 4) If the instrument still does not complete a successful self-test, additional time in 'stand-by' mode may be required. Repeat steps 1-3. 5) If repeated attempts do not yield a successful calibration test, then remove the instrument from service and contact Baxter Global Technical Services. Any questions were referred to the Center for One Baxter at 1-800-422-9837.

    Distribution

    Nationwide and internationally to China and Belgium

    Quantity

    264 units