BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DSU-H

    MDR report key: 7397667 · Received April 4, 2018

    Report

    Report Number
    3003337893-2018-00001
    Event Type
    Malfunction
    Date Received
    April 4, 2018
    Date of Event
    January 25, 2018
    Report Date
    April 4, 2018
    Manufacturer
    NEPHROS INC
    Product Code
    NHV
    UDI-DI
    00896241002343
    PMA / PMN Number
    5090885
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    WHEN INITIALLY EVALUATION WITHOUT THE PRODUCT RETURN, IT WAS CONCLUDED THAT THE EVENT WAS NOT MDR REPORTABLE AND WAS LIKELY THAT NEPHROS DISINFECTION AND INSTALLATION PROCEDURES WERE NOT FOLLOWED. NONETHELESS, AFTER A COMPLETE INVESTIGATION THERE WAS INDEED FIBER BREAKS IN BOTH BUNDLES OF THE FILTER WHICH COULD ALLOW BACTERIA TO PASS THROUGH. THEREFORE, FROM THE INFORMATION GATHERED ON 03/05/2018, THIS IS AN REPORTABLE EVENT.

    Description of Event or Problem · 1

    ON (B)(6) 2018 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 WAS 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 TEST THEIR WATER AT THEIR ICE MACHINE AND FOUND THAT THERE WAS POSITIVE BACTERIA DETECTED. FROM THE INITIAL DISCUSSION, IT IS LIKELY THAT OUR DISINFECTION AND INSTALLATION PROCEDURES WERE NOT FOLLOWED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    238560 DSU-H SYSTEM, WATER PURIFICATION, GENERAL MEDICAL U, PRODUCT CODE: NHV NHV NEPHROS INC 70-0285 PI17/0342 00896241002343

    Patients

    Seq Age Sex Outcome Treatment
    1