BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMART EZ PUMP

    MDR report key: 8688719 · Received June 11, 2019

    Report

    Report Number
    8688719
    Event Type
    Injury
    Date Received
    June 11, 2019
    Date of Event
    May 23, 2019
    Report Date
    June 4, 2019
    Manufacturer
    PROGRESSIVE MEDICAL, INC.
    Product Code
    MEB
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ON 05/22 - PT CONNECTED TO DISPOSABLE INFUSION DEVICE (SMART Z) FOR 46 HRS. INFUSION OF FLUOROURACIL. PT RETURNED TO INFUSION SUITE AM 05/23 AFTER NOTING VISIBLE BLOOD IN TUBING FROM PORT NEEDLE SITE TO INFUSION PUMP. WRAPPING HAD BEEN APPLIED TO SITE OF NEEDLE / PUMP CONNECTION AT TIME PUMP PLACED 05/22 TO INSURE TIGHT CONNECTION. AT TIME OF ARRIVAL TO CHO, TAPE NOTED WET WITH 5FU RESIDUE PRESENT ON PT'S UPPER ABDOMEN. ALL CLAMPS EXAMINED AND WERE OPEN. PHYSICIAN NOTIFIED, PHARMACY RECALIBRATED DOSE FOR 24 HR 5FU INFUSION. PT DISCHARGED TO HOME WITH INFUSION VIA CADD PUMP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    479383 SMART EZ PUMP EZ SMART PUMP MEB PROGRESSIVE MEDICAL, INC. C8M04

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention