BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEPHROS

    MDR report key: 23657689 · Received November 26, 2025

    Report

    Report Number
    3003337893-2025-00001
    Event Type
    Malfunction
    Date Received
    November 26, 2025
    Date of Event
    October 16, 2025
    Report Date
    November 14, 2025
    Manufacturer
    NEPHROS
    Product Code
    NHV
    UDI-DI
    20896241002385
    PMA / PMN Number
    K141731
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONA INFORMATION: THIS MDR WAS REPORTED LATE AS NEPHROS IS AWAITING FDA ESG NEXTGEN ACCOUNT SETUP/VERIFICATION.

    Description of Event or Problem · 0

    ON 10/16/2025 IT WAS REPORTED THAT A HEALTHCARE FACILITY RECEIVED A POSITIVE CULTURE DOWNSTREAM OF A DSU-H (70-0285) IN ONE OF THEIR ICE MACHINES. THERE WERE NO REPORTED ADVERSE EVENTS. NEPHROS DSU-H IS AN IN-LINE WATER FILTER, CLASS II MEDICAL DEVICE THAT IS PLACED BEFORE ICE MACHINES IN HEALTH CARE FACILITIES IN ORDER TO RETAIN BACTERIA, VIRUS AND ENDOTOXIN. THE USER FACILITY ROUTINELY TEST THEIR WATER AT THEIR ICE MACHINE AND FOUND THAT THERE WAS POSITIVE BACTERIA DETECTED. A POSITIVE CULTURE CAN BE CAUSED BY AN IMPROPER DISINFECTION OF THE ICE MACHINE OR WATER LINES LEADING TO THE ICE MACHINE, AND/OR A BREACH OF THE FILTER MEMBRANE. THE ROOT CAUSE OF THE POSITIVE CULTURE COULD NOT BE CONFIRMED AS THE FILTER WAS NOT RETURNED FOR ADDITIONAL INVESTIGATION. COMPREHENSIVE REVIEW OF THE SPECIFIC FILTER DEVICE HISTORY RECORD AND MANUFACTURING INSPECTIONS DID NOT IDENTIFY ANY PRODUCT ISSUES INCLUDING DEVICE MALFUNCTION/DEFECT. ADDITIONAL INFORMATION INCLUDING RETURN OF THE DEVICE ARE NEEDED TO FULLY INVESTIGATE THE EVENT. IF ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL/FOLLOW-UP REPORT WILL BE SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1947608 NEPHROS DSU-H NHV NEPHROS DSU-H PI25/0086 20896241002385

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown