BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CADD EXTENSION SET

    MDR report key: 22190131 · Received June 11, 2025

    Report

    Report Number
    3012307300-2025-06919
    Event Type
    Malfunction
    Date Received
    June 11, 2025
    Date of Event
    May 15, 2025
    Report Date
    June 11, 2025
    Manufacturer
    ICU MEDICAL, INC.
    Product Code
    FPA
    UDI-DI
    10610586023279
    PMA / PMN Number
    K974013
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    D4 LOT NUMBER INFORMATION PROVIDED BY THE CUSTOMER FOR POTENTIAL LOT NUMBERS WAS THE FOLLOWING: 6026917, 6024346, 6022118. H3, H6: NO PRODUCT WAS RETURNED. THE REPORTED COMPLAINT COULD NOT BE CONFIRMED. 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 MANUFACTURING.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PUMP WAS ALARMING FOR A NON-DISPOSABLE CASSETTE. THE TREATMENT WAS DELAYED FOR 12 HOURS. THE EVENT OCCURRED WHILE IN USE WITH PATIENT, AND THE PATIENT WAS NOT HARMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2202378 CADD EXTENSION SET SET, ADMINISTRATION, INTRAVASCULAR FPA ICU MEDICAL, INC. 7106 NI 10610586023279

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown