BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DOSI-FUSER, 4.7ML/HR-250ML 2 DAYS

    MDR report key: 5204230 · Received November 3, 2015

    Report

    Report Number
    MW5057687
    Event Type
    Malfunction
    Date Received
    November 3, 2015
    Date of Event
    September 25, 2015
    Report Date
    October 21, 2015
    Manufacturer
    LEVENTON, SAU
    Product Code
    MEB
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    PATIENT RECEIVED FLUOROURACIL CIVI VIA DOSI-FUSER ELASTOMERIC PUMP. INFUSION DESIGNED TO LAST 46 HOURS. PATIENT REPORTED PUMP EMPTY AT 24 HOURS AND RN DOCUMENTED IT EMPTY AT 30 HRS. PATIENT EXPERIENCED SEVERE N AND V WITH 7# WEIGHT LOSS. DOSE OR AMOUNT: 4800MG/46HRS; FREQUENCY: Q 14 DAYS; ROUTE: CIVI. DATES OF USE: (B)(6) 2015. DIAGNOSIS OR REASON FOR USE: COLON CA. EVENT ABATED AFTER USE STOPPED OR DOSE REDUCED: YES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    730174 DOSI-FUSER, 4.7ML/HR-250ML 2 DAYS ELASTOMERIC INFUSION PUMP MEB LEVENTON, SAU 401034 15857L

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Other