BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DOSI-FUSER

    MDR report key: 5179849 · Received October 19, 2015

    Report

    Report Number
    MW5057310
    Event Type
    Malfunction
    Date Received
    October 19, 2015
    Date of Event
    October 2, 2015
    Report Date
    October 19, 2015
    Manufacturer
    LEVENTON, SAU
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IN, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    PATIENT RETURNED TO CLINIC TO DISCONNECT DOSIFUSER. PATIENT NOTIFIED NURSE OF WHITE POWDER AROUND RESTRICTOR ELEMENT OF DOSIFUSER TUBING-NURSE IN TURN NOTIFIED PHARMACIST. PHARMACIST WITNESSED WHITE POWDER NURSE WIPED OFF POWDER WITH MOIST TOWELETTE MINOR SKIN IRRITATION NOTED UPON RETURNING TO CLINIC 2 WEEKS LATER PATIENT STATED SKIN HAD GOTTEN RED AND IRRITATED NEXT DAY AND NOW APPEARS TO BE HEALED OVER, POSSIBLY CHEMICAL BURN. PHARMACIST AND NURSE DETERMINED THE RESTRICTOR ELEMENT EITHER CRACKED OR NOT SEALED PROPERLY. POWDER PROBABLY DRIED FLUOROURACIL. SENT EMAIL TO MANUFACTURER WITH LOT NUMBER TO DETERMINE OTHER POSSIBLE INCIDENTS. DOSE OR AMOUNT: FLUOROURACIL 3700MG; FREQUENCY: EVERY 2 WEEKS; ROUTE: VIA 2 DAY INFUSOR. DATES OF USE:(B)(6) 2015. DIAGNOSIS OR REASON FOR USE: ADENOCARCINOMA. EVENT ABATED AFTER USE STOPPED OR DOSE REDUCED, YES. STRENGTH: 100ML - 2 DAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    689844 DOSI-FUSER DOSI-FUSER FPA LEVENTON, SAU 150431L

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR