BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PHOENIX

    MDR report key: 10367154 · Received August 5, 2020

    Report

    Report Number
    10367154
    Event Type
    Malfunction
    Date Received
    August 5, 2020
    Date of Event
    June 18, 2020
    Report Date
    June 22, 2020
    Manufacturer
    GAMBRO DASCO SPA
    Product Code
    KDI
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    ND
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    MACHINE SHOWS "HIGH LEVEL IN UF VESSEL" ALARM. UNABLE TO CLEAR ALARM. DIFFERENT MACHINE SET UP, PATIENT RINSED BACK AND PLACED ON DIFFERENT MACHINE TO FINISH TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    833425 PHOENIX DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM KDI GAMBRO DASCO SPA PHOENIX SP00185

    Patients

    Seq Age Sex Outcome Treatment
    1