BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PHOENIX

    MDR report key: 12352888 · Received August 23, 2021

    Report

    Report Number
    12352888
    Event Type
    Malfunction
    Date Received
    August 23, 2021
    Date of Event
    July 5, 2021
    Report Date
    July 30, 2021
    Manufacturer
    GAMBRO DASCO SPA
    Product Code
    KDI
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    ND
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    PATIENT WAS RUNNING ON MACHINE FOR 3.5 HOURS WHEN THE GENERAL SAFETY WHICH FLASHES WITH RED STARTED ALARMING. MACHINE WAS SHUT OFF. MANUAL RINSEBACK WAS GIVEN WITH NO PROBLEMS. PATIENT CHOSE JUST TO GET OFF AT THIS TIME. UNIT WAS SHOWING A GENERAL FAILURE. MANUFACTURER RESPONSE FOR HEMODIALYSIS, (BRAND NOT PROVIDED) (PER SITE REPORTER). UPDATE SOFTWARE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1249812 PHOENIX DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM KDI GAMBRO DASCO SPA 6023006700

    Patients

    Seq Age Sex Outcome Treatment
    1