BEUDAMED
    FDA Adverse Event Death Summary report: N

    SAFET SPOUT

    MDR report key: 3352811 · Received September 13, 2013

    Report

    Report Number
    MW5031803
    Event Type
    Death
    Date Received
    September 13, 2013
    Report Date
    September 12, 2013
    Manufacturer
    NEPHROS INC
    Product Code
    FIP
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    INFANTS IN THE REGIONAL NEWBORN CENTER DEVELOPED PSEUDOMONAS INFECTIONS. IT WAS DETERMINED THAT THE NEPHROS SAFE SPOUT FILTERS USED IN THAT AREA WERE CONTAMINATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    462828 SAFET SPOUT SAFET SPOUT FIP NEPHROS INC REF 70-0238 PM13/0027

    Patients

    Seq Age Sex Outcome Treatment
    1 7 DA Death