BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FRESENIUS NXSTAGE CONTROL UNIT NX2000-1

    MDR report key: 14374581 · Received May 11, 2022

    Report

    Report Number
    MW5109640
    Event Type
    Malfunction
    Date Received
    May 11, 2022
    Date of Event
    August 26, 2021
    Report Date
    March 24, 2022
    Manufacturer
    NXSTAGE MEDICAL, INC.
    Product Code
    FKR
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NY, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    PATIENT HAD NXSTAGE CONTROL UNIT FAILURE AFTER MULTIPLE PAK PRIME ERRORS. EQUIPMENT WAS SWAPPED PT HAD AN OUT OF BOX FAILURE RESULTING IN ANOTHER SWAP OF EQUIPMENT. PT USED HANGING BAGS FOR ONE WEEK CAUSING DISRUPTION IN HEMODIALYSIS PRESCRIPTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2382281 FRESENIUS NXSTAGE CONTROL UNIT NX2000-1 SUBSYSTEM, PROPORTIONING FKR NXSTAGE MEDICAL, INC. NX2000-1
    2382282 FRESENIUS NXSTAGE CONTROL UNIT NX2000-1 SUBSYSTEM, PROPORTIONING FKR NXSTAGE MEDICAL, INC. NX2000-1

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Female Other