BEUDAMED
    FDA Adverse Event Summary report: N

    DOSI-FUSER

    MDR report key: 7645524 · Received June 27, 2018

    Report

    Report Number
    MW5078111
    Date Received
    June 27, 2018
    Manufacturer
    LEVENTON S. A. U.
    Product Code
    MEB
    Report Source
    Voluntary report
    Reporter Location
    MD, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    TWO INCIDENTS WERE REPORTED REGARDING 5-FU USING DOSI-FUSER ON (B)(6) 2018AND (B)(6) 2018. IN BOTH CASES, THE CHEMO WAS FOUND TO BE LEAKING THROUGH THE DOSI-FUSER. THESE INCIDENCES DID NOT REACH THE DESIGNATED PATIENTS AS THEY WERE DISCOVERED BY THE INFUSION NURSE AT THE CLINIC PRIOR TO ADMINISTRATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    486718 DOSI-FUSER ELASTOMERIC PUMP MEB LEVENTON S. A. U. L25915-260D2 1801741L
    486719 DOSI-FUSER ELASTOMERIC PUMP MEB LEVENTON S. A. U. 180459L

    Patients

    Seq Age Sex Outcome Treatment
    1