BEUDAMED
    FDA Adverse Event Other Summary report: N

    ZYZATECH F-800-801 INSERT

    MDR report key: 273746 · Received April 12, 2000

    Report

    Report Number
    3019131-2000-00003
    Event Type
    Other
    Date Received
    April 12, 2000
    Report Date
    March 15, 1999
    Manufacturer
    OSMONICS, INC./KENT OPERATIONS
    Product Code
    FIP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    A NURSE AT A DIALYSIS FACILITY IS CONCERNED THAT THE MACHINES ARE UNSTABLE AND PRONE TO TIPPING OVER WHEN BEING MOVED AROUND. THE "MACHINE" IS A COMBINATION DIALYSIS MACHINE (FRESENIUS) WITH A SMALL PORTABLE "RO" INSERTED INTO THE BODY OF THE MACHINE. THE UNIT IS THEN ATTACHED TO TWO LEGS (RUNNERS) WHICH EXTEND OUTWARD TO THE REAR TO ACCOMODATE TWO CARBON TANKS AND LARGE CASTERS TO TRANSPORT THE UNIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ZYZATECH F-800-801 INSERT PORTABLE WATER PURIFICATION FOR HEMODIALYSIS - RO FIP OSMONICS, INC./KENT OPERATIONS F-800-801 *

    Patients

    Seq Age Sex Outcome Treatment
    1 *