BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NXSTAGE CARTRIDGE EXPRESS

    MDR report key: 6192674 · Received December 21, 2016

    Report

    Report Number
    6192674
    Event Type
    Malfunction
    Date Received
    December 21, 2016
    Date of Event
    November 23, 2016
    Report Date
    December 1, 2016
    Manufacturer
    NXSTAGE MEDICAL, INC.
    Product Code
    KDI
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    A CONTINUOUS RENAL REPLACEMENT THERAPY CARTRIDGE WAS REPORTED BY SURGICAL ICU STAFF TO BE SUCKING IN AIR THROUGH THE EFFLUENT FILTER LOCATED ON THE VENOUS LINE. THEY HAVE REPORTED THAT THIS HAS HAPPENED ON NUMEROUS CARTRIDGES FROM THIS LOT NUMBER. SICU STAFF DISCARDED THE FILTER BEFORE CLINICAL ENGINEERING WAS NOTIFIED OF THE SITUATION, BUT THEY DID REPORT THE EVENT TO THE MANUFACTURER, NXSTAGE. NO HARM CAME TO THE PATIENTS WHILE THIS LOT NUMBER OF CARTRIDGES WERE BEING USED. THE SICU STAFF NOTIFIED THE MANUFACTURER. SINCE THE CARTRIDGE WAS DISCARDED, THE MANUFACTURER ENCOURAGED STAFF TO FOLLOW UP IF/WHEN THIS OCCURS AGAIN SO THAT THEY CAN ACTIVELY INVESTIGATE THE ISSUE. THE MANUFACTURER HAS ALSO REACHED OUT TO IDENTIFY MORE INFORMATION ON THE NXSTAGE UNIT THAT THIS CARTRIDGE WAS BEING USED ON. THEY ARE ALSO SENDING US A RETURN KIT SO THAT THEY CAN INVESTIGATE A CARTRIDGE OF THE SAME LOT NUMBER BEING REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    845494 NXSTAGE CARTRIDGE EXPRESS DIALYZER, HIGH PERMEABILITY KDI NXSTAGE MEDICAL, INC. 60878011

    Patients

    Seq Age Sex Outcome Treatment
    1