BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMEPUMP C100020

    MDR report key: 439820 · Received January 23, 2003

    Report

    Report Number
    MW1027346
    Event Type
    Malfunction
    Date Received
    January 23, 2003
    Date of Event
    January 23, 2003
    Report Date
    January 23, 2003
    Manufacturer
    I-FLOW CORP.
    Product Code
    MEB
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NY, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    PT USING HOMEPUMP C100020 FOR CONTINUOUS DELIVERY OF FLUOROURACIL. PT REPORTED LEAKAGE THROUGH VENT HOLE IN FILTER OF HOMEPUMP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HOMEPUMP C100020 ELASTROMETRIC INFUSION SYSTEM MEB I-FLOW CORP. C100020 2A2508

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Other