BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OSMO 23G

    MDR report key: 565185 · Received December 20, 2004

    Report

    Report Number
    565185
    Event Type
    Malfunction
    Date Received
    December 20, 2004
    Date of Event
    December 9, 2004
    Report Date
    December 16, 2004
    Manufacturer
    GE OSMONICS
    Product Code
    JRS
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AR, US

    Narratives

    Description of Event or Problem · 1

    WATER WAS BEING PRODUCED BY THE RO, REVERSE OSMOSIS, SYSTEM, BUT WAS NOT ABLE TO REACH THE STORAGE TANK AND OUT TO THE LOOP. THE WATER LEVEL IN THE STORAGE TANK DROPPED TO 70 GALLONS, WHICH PUT THE SYSTEM INTO AN AUTOMATIC SHUT OFF MODE. IN AN EFFORT TO CONSERVE ON WATER THAT WAS NOT BEING PRODUCED BY THE RO SYSTEM, THE DIALYSATE FLOW ON ALL MACHINES WAS TURNED DOWN BY THE STAFF FROM 800 CC/MIN TO 500CC/MIN. THIS WOULD AFFECT THE AMOUNT OF UREA CLEARANCE DURING THE PATIENT'S NORMAL TREATMENT.THE PROBLEM TURNED OUT TO BE 2 VALVES WHICH WERE REPLACED. THIS PROBLEM HAS OCCURRED ONE OTHER TIME IN THE PAST.FURTHER FOLLOW UP REVEALED THAT THE STAFF WERE ALERTED OF THE PROBLEM BY THE SAFETY ALARM ON THE RO SYSTEM. THE OUTSIDE COMPANY THAT MAINTAINS THE SYSTEM CHANGED THE VALVES AND CHECKED THE WATER AFTER THE SYSTEM WAS REPAIRED. THE STAFF ALSO DOUBLE CHECKED THE WATER QUALITY TO MAKE SURE THAT THERE WERE NO PROBLEMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OSMO 23G REVERSE OSMOSIS PURFICATION MACHINE JRS GE OSMONICS 23G-HR(PA)4500 *

    Patients

    Seq Age Sex Outcome Treatment
    1 *