BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DSU-D

    MDR report key: 7112518 · Received December 13, 2017

    Report

    Report Number
    3003337893-2017-00001
    Event Type
    Malfunction
    Date Received
    December 13, 2017
    Date of Event
    October 16, 2017
    Report Date
    October 30, 2017
    Manufacturer
    NEPHROS, INC.
    Product Code
    NHV
    UDI-DI
    00896241002343
    PMA / PMN Number
    5090885
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    NEPHROS RECEIVED A REPORT FROM A USER FACILITY ADVISING US THAT ONE OF THEIR ICE MACHINES TESTED POSITIVE WITH AN UNSPECIFIED SPECIES OF BACTERIA. THERE WERE NO REPORTED ADVERSE EVENTS OR HEALTH ISSUES CONNECTED WITH THE POSITIVE RESULT. 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 TESTS THEIR WATER AT THE ICE MACHINE AND FOUND THAT THERE WAS POSITIVE BACTERIA DETECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    891256 DSU-D SYSTEM, WATER PURIFICATION, GENERAL MEDICAL U NHV NEPHROS, INC. 70-0285 PI15/0360 00896241002343

    Patients

    Seq Age Sex Outcome Treatment
    1