BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NXSTAGE CRRT SOLUTION

    MDR report key: 24306455 · Received February 10, 2026

    Report

    Report Number
    MW5183634
    Event Type
    Malfunction
    Date Received
    February 10, 2026
    Date of Event
    February 5, 2026
    Report Date
    February 5, 2026
    Manufacturer
    FRESENIUS MEDICAL CARE RENAL THERAPIES GROUP, LLC.
    Product Code
    KPO
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    US
    Reporter Occupation
    PHARMACIST
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    WHEN SPIKING CVVH (CONTINUOUS VENO-VENOUS HEMOFILTRATION) BAG, THE CONNECTION CAME LOOSE VERY EASILY. SOME FLUID SPILLED OUT, BAG REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    371780 NXSTAGE CRRT SOLUTION DIALYSATE CONCENTRATE FOR HEMODIALYSIS (LIQUID OR POWDER) KPO FRESENIUS MEDICAL CARE RENAL THERAPIES GROUP, LLC. RFP401 25NG06027

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown