BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEPHROS SAFESPOUT

    MDR report key: 3605414 · Received December 5, 2013

    Report

    Report Number
    3003337893-2013-00013
    Event Type
    Malfunction
    Date Received
    December 5, 2013
    Report Date
    February 21, 2013
    Manufacturer
    NEPHROS, INC.
    Product Code
    FIP
    Removal / Correction Number
    3003337893-11/04/13/001-
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS: INTEGRITY TESTING OF THE FILTER INDICATED THERE WAS A BREACH IN THE FILTER SEALING COMPOUND.

    Description of Event or Problem · 1

    CUSTOMER REPORTED POSITIVE BACTERIAL CULTURE IN WATER SAMPLE AFTER INSTALLING THE NEPHROS POINT-OF-USE WATER FILTER IN THEIR FACILITY. CUSTOMER RETURNED FILTER TO NEPHROS FOR EVALUATION. UPON EVALUATION OF RETURNED FILTER IT WAS DETERMINED THAT THERE WAS A BREACH IN THE FILTER SEALING COMPOUND. NO ADVERSE EVENTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    631382 NEPHROS SAFESPOUT POINT-OF-USE WATER FILTERS FIP NEPHROS, INC. 70-0238 PM12/0180

    Patients

    Seq Age Sex Outcome Treatment
    1