BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CADD CASSETTE RESERVOIRS

    MDR report key: 25022554 · Received April 28, 2026

    Report

    Report Number
    3012307300-2026-04347
    Event Type
    Malfunction
    Date Received
    April 28, 2026
    Date of Event
    November 4, 2025
    Report Date
    April 29, 2026
    Manufacturer
    ICU MEDICAL HEALTHCARE MANUFACTURING S.A. DE C.V.
    Product Code
    FPA
    UDI-DI
    10610586032394
    PMA / PMN Number
    K081156
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING INSPECTION ACTIVITIES IN INSPECTION, LABELING, AND PACKAGING (ILP), LEAD PRODUCTION TECHNICIAN IDENTIFIED FIVE (5) UNITS WITH PARTICULATES OUT OF 66 INSPECTED UNITS FOR CSP LOT. THE IR SPECTRUM OF THE PARTICULATE BEST MATCHED THE PLASTIC WHICH MOST LIKELY COMPOSED OF POLYPROPYLENE, THERE WAS NO PATIENT INVOLVEMENT AND NO PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    537506 CADD CASSETTE RESERVOIRS SET, ADMINISTRATION, INTRAVASCULAR FPA ICU MEDICAL HEALTHCARE MANUFACTURING S.A. DE C.V. 6070571 10610586032394

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown