BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MELLENIUM

    MDR report key: 2082170 · Received April 21, 2011

    Report

    Report Number
    2082170
    Event Type
    Malfunction
    Date Received
    April 21, 2011
    Date of Event
    April 20, 2011
    Report Date
    April 21, 2011
    Manufacturer
    MAR COR PURIFICATION
    Product Code
    FIP
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NY, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    A PATIENT IN THE DIALYSIS UNIT WAS APPROXIMATELY 20 MINUTES INTO HER DIALYSIS WHEN THE REVERSE OSMOSIS MACHINE STARTED TO EMIT A BURNING SMELL AND PRODUCE A SMALL AMOUNT OF SMOKE. THE PATIENT WAS IMMEDIATELY REMOVED FROM THE DIALYSIS MACHINE AND WAS SENT BACK TO THE UNIT ALONG WITH OTHER PATIENTS IN THE AREA. ENGINEERING, BIOMED AND THE HEAD DIALYSIS TECHNICIAN ALL RESPONDED IMMEDIATELY AND THE REVERSE OSMOSIS MACHINE WAS TAKEN OUT OF SERVICE. UPON INITIAL INVESTIGATION BY THE SERVICE VENDOR, IT SEEMS POSSIBLE THAT THERE WAS A SHORT CIRCUIT CAUSED BY A SPILL OF FLUID WHICH PENETRATED THE FUSE AND ELECTRICAL PANEL. THE DIALYSIS UNIT WAS CLOSED FOR 3 HOURS TO CLEAN UP THE AREA. ALL NEPHROLOGISTS WERE INFORMED. THIS PATIENT RETURNED TO THE DIALYSIS UNIT IN THE EVENING AND HAD DIALYSIS TREATMENT COMPLETED. THE REVERSE OSMOSIS MACHINE REMOVED FROM SERVICE WILL UNDERGO FURTHER INVESTIGATION AND A SERIES OF SAFETY INSPECTIONS BY THE SERVICE VENDOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MELLENIUM PORTABLE REVERSE OSMOSIS MACHINE FIP MAR COR PURIFICATION MILLENIUM *

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR DIALYSIS