BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEPHROS

    MDR report key: 14601899 · Received June 6, 2022

    Report

    Report Number
    3003337893-2022-00001
    Event Type
    Malfunction
    Date Received
    June 6, 2022
    Date of Event
    May 2, 2022
    Report Date
    May 25, 2022
    Manufacturer
    NEPHROS
    Product Code
    NHV
    UDI-DI
    00896241002343
    PMA / PMN Number
    K141731
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    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. ADDITIONAL INFORMATION INCLUDING CULTURE RESULTS AND RETURN OF THE DEVICE ARE NEEDED TO FULLY INVESTIGATE THE EVENT. IF ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL/FOLLOW-UP REPORT WILL BE SUBMITTED. THIS MDR WAS REPORTED LATE AS NEPHROS IS AWAITING ESG ACCOUNT SETUP/VERIFICATION.

    Description of Event or Problem · 0

    ON (B)(6) 2022 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. ADDITIONAL INFORMATION INCLUDING CULTURE RESULTS AND 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
    705244 NEPHROS DSU-H NHV NEPHROS DSU-H PI21/0386 00896241002343

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown