BEUDAMED
    FDA Adverse Event Death Summary report: N

    MILLENIUM RO SYSTEM

    MDR report key: 6542253 · Received May 3, 2017

    Report

    Report Number
    3019131-2017-00002
    Event Type
    Death
    Date Received
    May 3, 2017
    Date of Event
    April 6, 2017
    Report Date
    May 3, 2017
    Manufacturer
    MAR COR PURIFICATION
    Product Code
    FIP
    PMA / PMN Number
    K964539
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DIALYSIS FACILITY REPORTED THAT THE PATIENT WAS DIALYZED UTILIZING WATER THAT HAD NOT BEEN PROCESSED BY THE PORTABLE RO SYSTEM. USER ERROR IS SUSPECTED AS THE FACILITY ACCIDENTALLY CONNECTED THE WATER HOSE ON THE DIALYSIS MACHINE TO THE DISINFECT PORT INSTEAD OF THE RO PRODUCT WATER OUTPUT PORT. DISINFECTANT WAS NOT ATTACHED TO THE HOSE OR IN THE MACHINE AT THE TIME OF THE INCIDENT. THE PATIENT WAS REPORTED TO HAVE BEEN ON LIFE SUPPORT PRIOR TO DIALYSIS TREATMENT. SOMETIME AFTER DIALYSIS, THE PATIENT WAS REMOVED FROM LIFE SUPPORT AND DIED. THE RO MACHINE HAS SINCE BEEN QUARANTINED, THOUGH THERE WAS NO REPORTED MACHINE MALFUNCTION OR REPORTED CORRELATION BETWEEN THE END OF DIALYSIS TREATMENT AND THE PATIENT DEATH. THE FACILITY CONFIRMED THE FEED WATER THAT WAS CONNECTED TO THE WRONG PORT ON THE MACHINE WAS DECHLORINATED AND TESTED PRIOR TO THE DIALYSIS TREATMENT. THIS COMPLAINT WILL CONTINUE TO BE MONITORED IN MAR COR PURIFICATION COMPLAINT SYSTEM. DEVICE NOT RETURNED TO MANUFACTURER.

    Description of Event or Problem · 1

    USER FACILITY REPORTED THAT A PATIENT WAS BEING DIALYZED WITH RO FEED WATER. THE RO SYSTEM'S WATER HOSE WAS CONNECTED TO THE WRONG OUTPUT PORT, THUS WATER USED IN DIALYSIS WAS NOT RO WATER. IT HAS BEEN REPORTED TO MCP THE PATIENT WAS ON LIFE SUPPORT PRIOR TO DIALYSIS TREATMENT. SOMETIME AFTER DIALYSIS TREATMENT (UNKNOWN AMOUNT OF TIME), THE PATIENT WAS REMOVED FROM LIFE SUPPORT AND SUBSEQUENTLY DIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    322538 MILLENIUM RO SYSTEM WATER PURIFICATION SYSTEMS AND PORTABLE REVERSE OSMOSIS SYSTEMS FIP MAR COR PURIFICATION ME14714

    Patients

    Seq Age Sex Outcome Treatment
    1 Death