BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CADD ADMINISTRATION SET

    MDR report key: 24308882 · Received February 10, 2026

    Report

    Report Number
    3012307300-2026-01130
    Event Type
    Malfunction
    Date Received
    February 10, 2026
    Date of Event
    January 13, 2026
    Report Date
    April 21, 2026
    Manufacturer
    ICU MEDICAL HEALTHCARE MANUFACTURING S.A. DE C.V.
    Product Code
    FPA
    UDI-DI
    10610586019791
    PMA / PMN Number
    K895046
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    D3 - MFR ESTABLISHMENT NAME: UPDATED. H3 AND H6 CODES - UPDATED. NO PRODUCT WAS RETURNED. THE REPORTED ISSUE CANNOT BE CONFIRMED AS NO PRODUCT WAS RETURNED FOR INVESTIGATION. IF THE PRODUCT IS RETURNED, THIS COMPLAINT WILL BE REOPENED FOR FURTHER INVESTIGATION. A DEVICE HISTORY RECORD (DHR) REVIEW WAS CONDUCTED WHICH INDICATED ALL INSPECTIONS WERE COMPLETED AND NO ISSUES WERE NOTED DURING MANUFACTURE.

    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 THE TUBING HAD BEEN FOUND BROKEN APPROXIMATELY 6 INCHES BELOW THE CONNECTION CLOSEST TO THE PORT, AND CHEMOTHERAPY HAD BEEN OBSERVED LEAKING FROM THE SITE. THE PUMP HAD BEEN POWERED OFF, AND THE CLAMP NEAREST THE PORT HAD BEEN CLOSED. CHEMOTHERAPY SPILL INSTRUCTIONS HAD BEEN REVIEWED, AND THE PATIENT HAD BEEN ADVISED TO CALL THE PHYSICIAN CLINIC IMMEDIATELY PER SFI. IT HAD BEEN REPORTED BY THE CHEMOTHERAPY NURSE THAT THE LEAK WAS LOCATED A COUPLE OF INCHES AWAY FROM WHERE THE TUBING HAD BEEN ATTACHED TO THE PUMP. THERE WAS NO INJURY. THE MEDICATION HAD BEEN 5-FU. THE EVENT OCCURRED WHILE IN USE WITH A PATIENT AT THE PATIENT'S HOME AND THE OPERATOR OF THE DEVICE WAS A HEALTH PROFESSIONAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    369312 CADD ADMINISTRATION SET SET, ADMINISTRATION, INTRAVASCULAR FPA ICU MEDICAL HEALTHCARE MANUFACTURING S.A. DE C.V. 6133266 10610586019791

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown