BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BICARBY

    MDR report key: 24321176 · Received February 12, 2026

    Report

    Report Number
    24321176
    Event Type
    Malfunction
    Date Received
    February 12, 2026
    Date of Event
    February 3, 2026
    Report Date
    February 3, 2026
    Manufacturer
    FRESENIUS MEDICAL CARE RENAL THERAPIES GROUP, LLC
    Product Code
    KPO
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    WI
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    PATIENT ON CRRT [CONTINUAL RENAL REPLACEMENT THERAPY] AND FLUID CAPSULE LINE SNAPPED. FLUID BAG UNUSABLE AND FLUID ALL OVER THE FLOOR. LOT NUMBER 25NG06037.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    382728 BICARBY DIALYSATE CONCENTRATE FOR HEMODIALYSIS (LIQUID OR POWDER) KPO FRESENIUS MEDICAL CARE RENAL THERAPIES GROUP, LLC RFP-401-G 25NG06037

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Male