BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CADD CASSETTE 100ML W/FLOWSTOP

    MDR report key: 12058186 · Received June 23, 2021

    Report

    Report Number
    MW5102098
    Event Type
    Malfunction
    Date Received
    June 23, 2021
    Date of Event
    May 28, 2021
    Report Date
    May 28, 2021
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    LHI
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IN, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    OUTBOUND. PT STATED ONE PREFILLED CASSETTE WOULD NOT SET UP CORRECTLY WITH PUMP, PATIENT HAD TO DISCARD EARLY PER NURSE INSTRUCTION, PATIENT HAD BACKUP OPENED ALREADY THAT WAS STILL GOOD AND WILL SELF MIX ONE CASSETTE ON 05/30. DEFECTIVE FULL CASSETTE (2-TONED BEEPING ALARMS ON BOTH INFUSION PUMPS SN (B)(4)): CADD CASSETTE 100 ML WITH FLOWSTOP ¿LOT# 4092491 EXP 01/18/2026), NO FURTHER DETAILS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    950420 CADD CASSETTE 100ML W/FLOWSTOP SET, I.V. FLUID TRANSFER LHI SMITHS MEDICAL ASD, INC. 4092491

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR