BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PHOENIX

    MDR report key: 10042587 · Received May 11, 2020

    Report

    Report Number
    10042587
    Event Type
    Malfunction
    Date Received
    May 11, 2020
    Date of Event
    April 1, 2020
    Report Date
    April 10, 2020
    Manufacturer
    GAMBRO DASCO SPA
    Product Code
    KDI
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    GETTING D1-D2 ERROR MESSAGE AFTER 2 HOURS AND 15 MINUTES OF HEMODIALYSIS. HEMODIALYSIS TREATMENT TERMINATED 15 MINUTES EARLY PER NURSE PRACTITIONER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    506719 PHOENIX DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM KDI GAMBRO DASCO SPA 6023006700

    Patients

    Seq Age Sex Outcome Treatment
    1 2555 DA