BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CADD EXTENSION SET

    MDR report key: 22720848 · Received August 5, 2025

    Report

    Report Number
    3012307300-2025-09325
    Event Type
    Malfunction
    Date Received
    August 5, 2025
    Date of Event
    July 14, 2025
    Report Date
    September 29, 2025
    Manufacturer
    ICU MEDICAL, INC
    Product Code
    FPA
    UDI-DI
    10610586023279
    PMA / PMN Number
    K974013
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H3: INVESTIGATION INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Additional Manufacturer Narrative · 0

    ONE USED EXTENSION SET WAS RECEIVED OF LOT NUMBER 4192053. AS RECEIVED, THERE WAS NO PHYSICAL DAMAGE OR OTHER ANOMALIES OBSERVED. FUNCTIONAL TESTING WAS PERFORMED AND THE REPORTED ISSUE WAS CONFIRMED. THE FILTER VENT WAS OBSERVED TO LEAK AT 5 PSI. THE COMPLAINT OF LEAKAGE CAN BE CONFIRMED. THE PROBABLE CAUSE IS DUE TO THE FILTER LOSING ITS HYDROPHOBIC PROPERTIES.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT FLUID WAS LEAKING FROM THE FILTER AREA. THE INFUSION IS USED TO ADMINISTER ANTIBODIES. THERE WAS PATIENT INVOLVEMENT AND NO PATIENT HARM REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2448538 CADD EXTENSION SET SET, ADMINISTRATION, INTRAVASCULAR FPA ICU MEDICAL, INC 4192053 10610586023279

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown