BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MILLENIUM HX

    MDR report key: 8345765 · Received February 15, 2019

    Report

    Report Number
    3019131-2019-00002
    Event Type
    Injury
    Date Received
    February 15, 2019
    Date of Event
    January 16, 2019
    Report Date
    February 15, 2019
    Manufacturer
    MAR COR PURIFICATION
    Product Code
    FIP
    UDI-DI
    00817492020771
    PMA / PMN Number
    K110578
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    THE FACILITY REPORTED OBSERVING A BROWN SUBSTANCE ON THE REVERSE OSMOSIS (RO) MEMBRANE IN THEIR MILLENIUM HX PORTABLE RO SYSTEM. THERE IS POTENTIAL FOR PATIENT OR USER EXPOSURE. THE FACILITY IMMEDIATELY REPLACED THE AFFECTED MEMBRANE IN THEIR RO SYSTEM AND HAS NOT EXPERIENCED ANY ISSUES. THE SOURCE OF THE BROWN SUBSTANCE WAS CONFIRMED TO BE THE ADHESIVE USED IN THE CONSTRUCTION OF THE MEMBRANE ITSELF. IT IS UNKNOWN IF THE SUBSTANCE IS ENTERING THE RO SYSTEM FLUID PATHWAY. ADDITIONAL TESTING AND INVESTIGATION IS UNDERWAY. THERE HAVE BEEN NO REPORTS OF ANY PATIENT ADVERSE EFFECTS. THIS REPORT IS BEING SUBMITTED CONSERVATIVELY AS THE POTENTIAL FOR PATIENT OR USER EXPOSURE TO THE SUBSTANCE IS UNKNOWN AT THIS TIME. THIS COMPLAINT WILL CONTINUE BEING MONITORED IN THE MAR COR PURIFICATION/CANTEL COMPLAINT HANDLING SYSTEM.

    Description of Event or Problem · 1

    THE FACILITY REPORTED OBSERVING A BROWN SUBSTANCE ON THE REVERSE OSMOSIS (RO) MEMBRANE IN THEIR MILLENIUM HX PORTABLE RO SYSTEM. THERE IS POTENTIAL FOR PATIENT OR USER EXPOSURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    138321 MILLENIUM HX WATER PURIFICATION SYSTEM FIP MAR COR PURIFICATION 00817492020771

    Patients

    Seq Age Sex Outcome Treatment
    1 Other