BEUDAMED
    FDA Recall Terminated

    Low Volume Cartridge IFU (SKU CAR-125-B) used with the following devices: 1) NxStage One, Model NX1000-1; 2) NxStage VersiHD Cycler, Model Numbers: NX1000-16, and NX1000-16-A; 3) NxStage One, Model Numbers: NX1000-3 and NX1000-3-A; 4) NxStage One, Model Numbers: NX1000-10 and NX1000-10-A;

    Recall: Z-0697-2020 · Initiated August 27, 2019

    Recall

    Recall Number
    Z-0697-2020
    Event Number
    83706
    Firm
    NxStage Medical, Inc.
    FEI Number
    3003464075
    Product Code
    PEV
    Status
    Terminated
    Root Cause
    Under Investigation by firm
    Initiated
    August 27, 2019
    Terminated
    February 1, 2021
    Address
    350 Merrimack St, Lawrence, MA, 01843-1748

    Description

    Low Volume Cartridge IFU (SKU CAR-125-B) used with the following devices: 1) NxStage One, Model NX1000-1; 2) NxStage VersiHD Cycler, Model Numbers: NX1000-16, and NX1000-16-A; 3) NxStage One, Model Numbers: NX1000-3 and NX1000-3-A; 4) NxStage One, Model Numbers: NX1000-10 and NX1000-10-A;

    Reason

    There is a potential patient health risk while performing chronic hemodialysis treatments in the home setting with for patients with low blood volume (2.4 Liters or less in a patient with body weight of 30kg or less) when prescribing larger dialysate volumes.

    Action

    On August 27, 2019, NxStage issued URGENT MEDICAL DEVICE CORRECTION notices to customers. Actions to be Taken by Customers: For patients using NxStage System One Cycler, model NX1000-1: - At any dialysate flow rate, the system may have a fluid removal error defined as the greater of 3% of Total Dialysate Volume or 300 ml/12hr. The Total Allowable Error is generally dependent on total dialysate volume processed for this System model. For patients using less than 10L of dialysate per treatment, this model has a minimum Total Allowable Error volume of 300 ml. For patients using NxStage System One S or NxStage VersiHD Cycler, model NX1000-3, NX1000-3A, NX1000-10, NX1000-10A, NX1000-16, or NX1000-16A: - At dialysate flow rates of 3.0 Liters/hour and below, the system may have a fluid removal error defined as the greater of up to 25 ml/hour or 5% of Total Ultrafiltration Volume. The Total Allowable Error is dependent on the error rate and length of treatment and can continue to increase for as long as treatment is being delivered. - At dialysate flow rates of above 3.0 Liters/hour, the system may have a fluid removal error defined as the greater of up to 100 ml/hour or 5% of Total Ultrafiltration Volume. The Total Allowable Error is dependent on the error rate and length of treatment and can continue to increase for as long as treatment is being delivered. NxStage discourages the use of the System for the treatment of low blood volume patients. If the physician considers it appropriate to prescribe home hemodialysis using the NxStage System One for low blood volume patients, the following points should be considered: 1. When performing hemodialysis treatments for low blood volume (2.4 Liters or less in a patient with body weight of 30kg or less) patients, NxStage strongly recommends employment of additional monitoring vigilance. Always ensure that cardiac status and fluid status are monitored for low blood volume patients by monitoring bloo

    Distribution

    AL, AZ, CA, NC & VA

    Quantity

    1803 units