BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DOSI-FUSOR

    MDR report key: 4208944 · Received October 10, 2014

    Report

    Report Number
    4208944
    Event Type
    Malfunction
    Date Received
    October 10, 2014
    Date of Event
    June 21, 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

    PATIENT REPORTED THAT HER CHEMO INFUSOR WAS CLOSE TO COMPLETION AND WAS NOT DUE FOR DISCONNECT UNTIL THE FOLLOWING AFTERNOON. PATIENT WAS CONNECTED TO CONTINUOUS INFUSION OF 5-FU CHEMO THERAPY VIA DOSI-INFUSOR. THE INFUSOR APPEARED TO HAVE COMPLETED 3/4 OF INFUSION WITH APPROXIMATELY 18 TO 20 HOURS BEFORE SCHEDULED DISCONNECT. PATIENT REPORTED SPENDING APPROXIMATELY 1 HOUR OUTSIDE IN THE SUN. PHOTOS TAKEN, NOTIFIED MD, DISCONTINUED INFUSION, PORT FLUSHED AND PORT NEEDLE D/C'D. PT WAS STABLE WITH NO SIGNS OR SYMPTOMS OF ADVERSE REACTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    643175 DOSI-FUSOR PUMP, ELASTOMERIC, INFUSION MEB LEVENTON, SAU N/A 140211L

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR