BEUDAMED
    FDA Recall Terminated

    2008 K2 Hemodialysis Machine with software version 5.40, Models: (1) Hemodialysis SYS OLC/Diasafe PLS 190610, UDI 00840861100859 (+Serial Number), (2) Machine Short Cap, OLC.DP HP 190630, UDI 00840861100866 (+Serial Number) ndicated for acute and chronic dialysis therapy.

    Recall: Z-1278-2018 · Initiated December 14, 2017

    Recall

    Recall Number
    Z-1278-2018
    Event Number
    79478
    Firm
    Fresenius Medical Care Renal Therapies Group, LLC
    FEI Number
    3001451489
    Product Code
    KDI
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    December 14, 2017
    Posted
    March 20, 2018
    Terminated
    September 22, 2021
    Address
    920 Winter St, Waltham, MA, 02451-1521

    Description

    2008 K2 Hemodialysis Machine with software version 5.40, Models: (1) Hemodialysis SYS OLC/Diasafe PLS 190610, UDI 00840861100859 (+Serial Number), (2) Machine Short Cap, OLC.DP HP 190630, UDI 00840861100866 (+Serial Number) ndicated for acute and chronic dialysis therapy.

    Reason

    When the recirculation ultrafiltration (UF) Goal is set to a value greater than 200ml in service mode and the user starts a treatment using the SLED (Sustained Low Efficiency Dialysis) program the display will show an invalid message and the UF pump will run at the recirculation UF rate which may be up to 4000ml/hour. The SLED program is required to limit the UF rate to a maximum of 1000 ml/hour.

    Action

    The recall notification instructs the user to the UF Goal with values less than 200ml when in Service Mode and to monitor and set the UF Rate to the desired setting after starting the SLED treatment. The consignee is advised that a software update is forthcoming to correct the issue. For further questions, please call (800) 227-2572.

    Distribution

    US Distribution to the states of: AR, CA, CO, FL, GA, IL, MA, MD, MN, NC, NY, OH, PA, SC, TN, and TX.

    Quantity

    127