BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DOSI-FUSOR

    MDR report key: 4208937 · Received October 10, 2014

    Report

    Report Number
    4208937
    Event Type
    Malfunction
    Date Received
    October 10, 2014
    Date of Event
    June 22, 2014
    Report Date
    October 10, 2014
    Manufacturer
    LEVENTON, SAU
    Product Code
    MEB
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US

    Narratives

    Description of Event or Problem · 1

    CHEMO INFUSOR APPEARED TO MALFUNCTION AS APPROXIMATELY 1/4 OF CHEMO INFUSED AFTER CLOSE TO 46 HOURS. VISITING NURSE SAW PATIENT AND CALLED TO REPORT ALL CLAMPS WERE OPEN AND PORT FLUSHED EASILY WITH BRISK BLOOD RETURN. INFUSOR WAS DISCONTINUED AT SCHEDULED TIME. SPOUSE SUBMITTED PHOTOS OF INFUSOR FOR EVALUATION VIA SMART PHONE. DEVICE WAS NOT RETRIEVED FROM THE HOME DUE TO HAZARDOUS DRUG CONTENTS BEING UNFIT FOR PHYSICAL INSPECTION BY THE MANUFACTURER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    642911 DOSI-FUSOR PUMP, ELASTOMERIC, INFUSION MEB LEVENTON, SAU 25915-250D2 14021 1L

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR CHEMOTHERAPY