BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMEPUMP BY I-FLOW MODEL (060020-A)

    MDR report key: 173832 · Received June 24, 1998

    Report

    Report Number
    MW1014053
    Event Type
    Malfunction
    Date Received
    June 24, 1998
    Date of Event
    June 11, 1998
    Report Date
    June 23, 1998
    Manufacturer
    I-FLOW CORP.
    Product Code
    MEB
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CO, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    THE HOMEPUMP FAILED TO INFUSE EITHER PART OR ALL OF THE DOSE OF 5 FU THAT IT CONTAINED ON 6/11/98, 6/17/98 AND 6/19/98.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HOMEPUMP BY I-FLOW MODEL (060020-A) ELASTOMERIC INFUSION DEVICE MEB I-FLOW CORP. HOMEPUMP 7B2058

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Other PT DOES HAVE AN INTRAVENOUS ACCESS DEVICE| (INFUSAPORT) IN.