BEUDAMED
    FDA Adverse Event Death Summary report: N

    NEPHROS SAFESPOUT AND SAFESHOWER FILTERS

    MDR report key: 3513983 · Received November 27, 2013

    Report

    Report Number
    3003337893-2013-00005
    Event Type
    Death
    Date Received
    November 27, 2013
    Date of Event
    February 28, 2013
    Report Date
    October 29, 2013
    Manufacturer
    NEPHROS, INC.
    Product Code
    FIP
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    BONE MARROW TRANSPLANT UNIT WITH PRE-EXISTING LEGIONELLA ISSUE IN THE HEALTHCARE FACILITY'S WATER SYSTEM INSTALLED NEPHROS POINT-OF-USE WATER FILTERS ON THE SINK FAUCET AND IN THE SHOWER STALL IN PATIENT'S ROOM IN (B)(6) 2012. PATIENT'S HAD UNDERGONE TRANSPLANT SURGERY (B)(6) 2013 AND LATER DIED ON (B)(6) 2013 OF MULTIPLE CAUSES, ONE OF WHICH INCLUDED LEGIONELLA INFECTION. THE LEGIONELLA STRAIN WAS SERO-TYPED BY THE CDC AND WAS MATCHED TO THE SAME STRAIN PREVIOUSLY IDENTIFIED IN THE HOSPITAL'S WATER SUPPLY. AT THE TIME OF THE EVENT, NO FILTERED WATER SAMPLES WERE TAKEN FROM THE POINT-OF USE FILTERS. ALSO, THE FILTERS THAT WERE IN USE AT THE TIME OF THE EVENT WERE DISCARDED AND NEVER RETURNED TO THE MFR FOR EXAMINATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    619371 NEPHROS SAFESPOUT AND SAFESHOWER FILTERS POINT-OF-USE WATER FILTERS FIP NEPHROS, INC. 70-0238, 70-0237

    Patients

    Seq Age Sex Outcome Treatment
    1 Death