BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CWP

    MDR report key: 23438300 · Received October 31, 2025

    Report

    Report Number
    23438300
    Event Type
    Malfunction
    Date Received
    October 31, 2025
    Date of Event
    September 29, 2025
    Report Date
    October 1, 2025
    Manufacturer
    EVOQUA WATER TECHNOLOGIES LLC
    Product Code
    FIP
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    ND
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    PATIENT MISSED 91 MIN. OF HD [HEMODIALYSIS] DUE TO THE RO [REVERSE OSMOSIS] SYSTEM BREAKING. BIOMED AWARE OF ONGOING ISSUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1076664 CWP SUBSYSTEM, WATER PURIFICATION FIP EVOQUA WATER TECHNOLOGIES LLC RO,CWP,20LPM,102H

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown