BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEPHROS SAFESPOUT

    MDR report key: 3456513 · Received October 24, 2013

    Report

    Report Number
    3003337893-2013-00001
    Event Type
    Injury
    Date Received
    October 24, 2013
    Date of Event
    August 1, 2013
    Report Date
    August 22, 2013
    Manufacturer
    NEPHROS, INC.
    Product Code
    FIP
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    NEONATAL UNIT WITH PRE-EXISTING PSEUDOMONAS ISSUE IN THE HEALTHCARE FACILITY'S WATER SYSTEM INSTALLED POINT-OF-USE WATER FILTERS ON THE SINK FAUCETS IN THE UNIT ((B)(6) 2013). FILTERED TAP WATER FROM THESE FAUCETS WAS THEN USED FOR PT CARE PURPOSES WHICH REPLACED USE OF STERILE WATER PRIOR TO INSTALLATION OF THE WATER FILTERS. PT CULTURED POSITIVE FOR A PSEUDOMONAS INFECTION ON (B)(6) 2013. FILTER FROM SAME COMMON TREATMENT AREA WAS RETURNED TO MANUFACTURER FOR INVESTIGATION. INTEGRITY TESTING OF FILTER INDICATED THERE WAS A BREACH IN THE FILTER MEMBRANE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    546330 NEPHROS SAFESPOUT POINT-OF-USE WATER FILTER FIP NEPHROS, INC. 70-0238 PM 13/0027

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization