BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMARTEZ DISPOSABLE INFUSION DEVICE

    MDR report key: 8688728 · Received June 11, 2019

    Report

    Report Number
    8688728
    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 CONNECT TO DISPOSABLE INFUSION DEVICE (SMART Z) FOR 46 HR. INFUSION OF FLUOROURACIL. PT RETURNED TO INFUSION SUITE AM 05/23 AFTER NOTING VISIBLE BLOOD IN TUBING FROM PORT NEEDLE SITE TO INFUSION PUMP. TAPE WRAPPING HAD BEEN APPLIED TO NEEDLE/PUMP CONNECTION AT TIME PUMP PLACED ON 05/22 TO ENSURE 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 INFUSION. PT DISCHARGED TO HOME WITH INFUSION VIA CADD PUMP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    479406 SMARTEZ DISPOSABLE INFUSION DEVICE SMARTEZ DISPOSABLE INFUSION DEVICE MEB PROGRESSIVE MEDICAL, INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Required Intervention