BEUDAMED
    FDA Adverse Event Summary report: N

    MILLENIUM RO SYSTEM

    MDR report key: 5104050 · Received September 25, 2015

    Report

    Report Number
    3019131-2015-00004
    Date Received
    September 25, 2015
    Date of Event
    August 27, 2015
    Report Date
    September 25, 2015
    Manufacturer
    MAR COR PURIFICATION
    Product Code
    FIP
    PMA / PMN Number
    K964539
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ON (B)(6), DIALYSIS CLINIC ACCIDENTALLY CONNECTED THE PRODUCT WATER LINE TO THE DISINFECTION PORT OF THE PORTABLE RO SYSTEM (PORTS ARE COLOR CODED, UNIT MANUFACTURED PRIOR TO 2005). ONE PATIENT WAS DIALYZED WITH DE-CHLORINATED WATER THAT HAD NOT BEEN TREATED BY THE REVERSE OSMOSIS WATER SYSTEM. CLINIC TESTED THE WATER AND FOUND ELEVATED SODIUM AND FLUORIDE LEVELS. NO PATIENT OR WORKER INJURIES WERE REPORTED. THIS COMPLAINT WILL CONTINUE TO BE MAINTAINED WITHIN THE MAR COR COMPLAINT SYSTEM.

    Description of Event or Problem · 1

    PATIENT WAS DIALYZED UTILIZING DE-CHLORINATED WATER THAT HAS NOT BEEN PROCESSED BY THE PORTABLE RO SYSTEM. BIOMED MANAGER WAS NOT AWARE OF ANY PATIENT ISSUES (ONE PATIENT).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    635727 MILLENIUM RO SYSTEM WATER PURIFICATION SYSTEMS AND PORTABLE REVERSE OSMOSIS SYSTEMS FIP MAR COR PURIFICATION MILLENIUM

    Patients

    Seq Age Sex Outcome Treatment
    1