BEUDAMED
    FDA Recall Terminated

    Baxter Meridian Hemodialysis Instrument, product codes 5M5576 and 5M5576R; Baxter Healthcare Corporation, Renal Division, McGaw Park, IL 60085 U.S.A.

    Recall: Z-0275-06 · Initiated September 28, 2005

    Recall

    Recall Number
    Z-0275-06
    Event Number
    33632
    Firm
    Baxter Healthcare Renal Div
    FEI Number
    3000210122
    Product Code
    KDI
    Status
    Terminated
    Root Cause
    Other
    Initiated
    September 28, 2005
    Posted
    December 14, 2005
    Terminated
    November 27, 2006
    Address
    1620 Waukegan Rd, Bldg R, Mc Gaw Park, IL, 60085-6730

    Description

    Baxter Meridian Hemodialysis Instrument, product codes 5M5576 and 5M5576R; Baxter Healthcare Corporation, Renal Division, McGaw Park, IL 60085 U.S.A.

    Reason

    Inadequate instructions for routing single tubing lines through the double-tubing clips on the front of the instrument to eliminate the risk of kinks in the tubing, which have been associated with a death and a serious injury.

    Action

    Urgent Device Recall letters dated 9/28/05 were sent to all Meridian accounts on the same date, to the attention of the Hemodialysis Administrator, with copies sent to the Chief Technician and Hemodialysis Charge Nurse. The letters informed the accounts of teh death and serious injury related to kinks in blood tubing sets used on the Meridian machine, and that there is an increased risk of kinks to occur at the double-tubing clips mounted on the front of the Meridian. The risk increases when a single tubing line is routed through both retainers on either clip. The letter included diagrams showing the correct and incorrect use of the clips, provided labels, with placement instructions, to be placed on the Meridian machine indicating the correct and incorrect placement of tubing, and informed the users that replacement clips with single channels will be installed when they become available. Follow-up letters were sent to the accounts on 12/22/05, providing training material to ensure that the accounts are aware of proper blood tubing set-up and understand the conditions which may result in hemolysis, and on 12/23/05, informing them that the replacement clips were available for installation, giving the accounts the option of having Baxter install them or sending the clips to the account for self-installation.

    Distribution

    Nationwide and internationally to Mexico and Asia.

    Quantity

    2,838 units