BEUDAMED
    FDA Adverse Event Other Summary report: N

    EASY PUMP

    MDR report key: 695257 · Received March 30, 2006

    Report

    Report Number
    2026095-2006-00023
    Event Type
    Other
    Date Received
    March 30, 2006
    Date of Event
    November 1, 2005
    Report Date
    March 10, 2006
    Manufacturer
    I-FLOW CORP.
    Product Code
    MEB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PUMP INFUSED IN 19 HOURS INSTEAD OF 44 HOURS (INFUSION STARTED ON 12/19/2005 AT 14:00 AND ENDED 12/20/2005 AT 07:30), AND THE NURSE NOTED THAT "RISK OF HIGH TOXICITY OF CHEMOTHERAPY". THE PUMP WAS FILLED WITH 91ML OF 5FU.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EASY PUMP INFUSION PUMP MEB I-FLOW CORP. 04434370 572064

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other