BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CADD MEDICATION CASSETTE

    MDR report key: 23017157 · Received September 10, 2025

    Report

    Report Number
    9617604-2025-00247
    Event Type
    Malfunction
    Date Received
    September 10, 2025
    Date of Event
    August 5, 2025
    Report Date
    September 10, 2025
    Manufacturer
    ICU MEDICAL, INC
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    TWO PHOTOS WERE RECEIVED FOR ANALYSIS. HOWEVER, THE INVESTIGATION COULD NOT IDENTIFY SUFFICIENT DETAIL FROM THE PHOTOS TO CONFIRM THE REPORTED ISSUE. AS NO LOT NUMBER COULD BE CONFIRMED, NO REVIEW OF DEVICE RECORDS COULD BE CONDUCTED. BASED ON THE RESULTS OF THE INVESTIGATION, THE REPORTED COMPLAINT COULD NOT BE CONFIRMED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING USE OF THE 100 ML YELLOW CADD CASSETTES, A CASSETTE CONTAINING A PARTICLE HAD BEEN IDENTIFIED THROUGH VISUAL INSPECTION. THE MAJORITY OF THE CASSETTES USED HAD COME FROM LOT 6070588; HOWEVER, SINCE UNITS FROM OTHER LOTS HAD ALSO BEEN USED, IT WAS NOT POSSIBLE TO SPECIFY A SINGLE LOT. THERE WAS NO REPORT OF PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1750179 CADD MEDICATION CASSETTE SET, ADMINISTRATION, INTRAVASCULAR FPA ICU MEDICAL, INC UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown