BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEPHROS SAFESPOUT

    MDR report key: 3642993 · Received December 20, 2013

    Report

    Report Number
    3003337893-2013-00030
    Event Type
    Malfunction
    Date Received
    December 20, 2013
    Report Date
    August 30, 2012
    Manufacturer
    NEPHROS, INC.
    Product Code
    FIP
    Removal / Correction Number
    Z-0487-2014
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    OTHER (UNSPECIFIED CODE): INTEGRITY TESTING OF THE FILTER INDICATED THERE WAS A BREACH IN THE FILTER MEMBRANE. NEPHROS SAFESPOUT FILTERS (11 FROM LOT PM12/0022) WERE RETURNED TO NEPHROS FOR COMPLAINT EVALUATION ON (B)(6) 2012 AS A PREVENTIVE MEASURE BECAUSE OF SUSPECTED POSITIVE BACTERIAL CULTURES FROM WATER SAMPLES COLLECTED AT THE FILTER OUTLET. NEPHROS WAS ABLE TO TEST THE FILTERS FOR INTEGRITY USING AN AIR PRESSURE HOLDING TEST. THE FILTERS TESTED FAILED TO HOLD PRESSURE INDICATING THERE WAS A BREACH IN THE FILTER MEMBRANE. AT THIS POINT IN TIME, WE ARE NOT ABLE TO DRAW ANY FINAL CONCLUSIONS TO THE ROOT CAUSE OF THE FILTER FAILURES.

    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 MEMBRANE. NO ADVERSE EVENTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    669618 NEPHROS SAFESPOUT POINT-OF-USE WATER FILTERS FIP NEPHROS, INC. 70-0233 PM12/0022

    Patients

    Seq Age Sex Outcome Treatment
    1