BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PHOENIX

    MDR report key: 492168 · Received October 24, 2003

    Report

    Report Number
    9616240-2003-00014
    Event Type
    Malfunction
    Date Received
    October 24, 2003
    Date of Event
    September 23, 2003
    Report Date
    September 25, 2003
    Manufacturer
    GAMBRO DASCO
    Product Code
    KDI
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE PHOENIX MACHINE PULLED 4 KGS OF FLUID OFF OF PT IN THE FIRST HOUR. PT STARTED TO FEEL BAD: PT STARTED COMPLAINING OF CRAMPING, HYPOTENSION, DIZZINESS AND WEAKNESS. TARGET WEIGHT REMOVAL WAS 3.4 KGS. TREATMENT TIME WHEN SYMPTOMS STARTED WAS 1 HOUR AND 15 MINUTES. PT WAS WEIGHED AT THE BEDSIDE WHEN THE SYMPTOMS WERE PRESENT. PT WAS GIVEN REPLACEMENT FLUID. TREATMENT WAS RESTARTED ON A DIFFERENT MACHINE AND WAS TERMINATED WITHOUT INCIDENT. PT DISCHARGED VIA AMBULATORY. CUSTOMER SAID THAT THEIR BIOMEDICAL WAS PRESENT AND A LINE WAS DISCONNECTED AND THE MACHINE WAS NOT HOLDING PRESSURES. AIR WAS LEAKING INTO THE SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PHOENIX HEMODIALYSIS EQUIPMENT KDI GAMBRO DASCO PHOENIX NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention