BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PHOENIX

    MDR report key: 10173504 · Received June 19, 2020

    Report

    Report Number
    10173504
    Event Type
    Malfunction
    Date Received
    June 19, 2020
    Date of Event
    May 15, 2020
    Report Date
    May 19, 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

    WITH 25 MINUTES LEFT IN THE PATIENT'S TREATMENT HE STARTED GETTING FLOW METER FAILURE ALARMS 144,104,300 THAT WERE NOT ABLE TO BE CLEARED. IT WAS NOTED THAT THE DIALYSIS MACHINE WAS DRIPPING INTO THE PAN FROM UNDERNEATH THE FRONT COVER IN THE CENTER ASPECT. PATIENT'S RUN WAS DISCONTINUED. A WORK ORDER WAS CALLED IN AS WELL AS BIOMED TECH PERSONALLY NOTIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    638757 PHOENIX DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM KDI GAMBRO DASCO SPA PHOENIX

    Patients

    Seq Age Sex Outcome Treatment
    1 21170 DA