BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NXSTAGE CARTRIDGE EXPRESS

    MDR report key: 12445944 · Received September 9, 2021

    Report

    Report Number
    12445944
    Event Type
    Malfunction
    Date Received
    September 9, 2021
    Date of Event
    August 10, 2021
    Report Date
    August 17, 2021
    Manufacturer
    NXSTAGE MEDICAL, INC.
    Product Code
    KDI
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AZ
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 0

    STAFF REPORT THAT THE NXSTAGE MEDICAL, INC. CARTRIDGES, USED FOR CONTINUOUS RENAL REPLACEMENT THERAPY, ARE ONLY LASTING 4 HOURS BECAUSE THE CARTRIDGES ARE SEPARATING DURING USE.

    Description of Event or Problem · 1

    STAFF REPORT THAT THE NXSTAGE MEDICAL, INC. CARTRIDGES, USED FOR CONTINUOUS RENAL REPLACEMENT THERAPY, ARE ONLY LASTING 4 HOURS BECAUSE THE CARTRIDGES ARE SEPARATING DURING USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1343933 NXSTAGE CARTRIDGE EXPRESS DIALYZER, HIGH PERMEABILITY W OR W/O SEALED DIALYSATE SYSTEM KDI NXSTAGE MEDICAL, INC. CAR-505 10378006

    Patients

    Seq Age Sex Outcome Treatment
    1 16060 DA