BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CASSETTE MEDI RESERVOIR

    MDR report key: 12681695 · Received October 21, 2021

    Report

    Report Number
    MW5104848
    Event Type
    Malfunction
    Date Received
    October 21, 2021
    Date of Event
    August 3, 2021
    Report Date
    August 3, 2021
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    LHI
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    SPONTANEOUS CALL FROM PATIENT WITH PROBLEM WITH CASSETTES WHEN DOING HER MIX. THE LOT NUMBERS ARE 4063419 AND 4135512. THE CASSETTES WOULD NOT ALLOW FOR ANY BUBBLES TO BE REMOVED AND HAD TOO LARGE OF AIR BUBBLES. NO INTERRUPTION IN THERAPY AND NO ADVERSE EVENT. REPORTED TO (B)(6) BY PT/CAREGIVER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1568004 CASSETTE MEDI RESERVOIR SET, I.V. FLUID TRANSFER LHI SMITHS MEDICAL ASD, INC. 4063419
    1568005 CASSETTE MEDI RESERVOIR SET, I.V. FLUID TRANSFER LHI SMITHS MEDICAL ASD, INC. 4135512

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR