BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CADD MEDICATION CASSETTE RESERVOIR

    MDR report key: 22579439 · Received July 23, 2025

    Report

    Report Number
    3012307300-2025-08879
    Event Type
    Malfunction
    Date Received
    July 23, 2025
    Date of Event
    July 3, 2025
    Report Date
    August 26, 2025
    Manufacturer
    ICU MEDICAL, INC
    Product Code
    FPA
    UDI-DI
    10610586032387
    PMA / PMN Number
    K081156
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATION: ONE DEVICE WAS RECEIVED FOR DEVICE ANALYSIS. SERVICE HISTORY REVIEW IDENTIFIED THE COMPLAINT WAS NOT RELATED TO A PREVIOUS SERVICE OF THE DEVICE WITHIN THE REVIEW PERIOD. FUNCTIONAL TESTING AND VISUAL INSPECTION PERFORMED DURING ANALYSIS. THE CUSTOMER REPORTED COMPLAINT COULD NOT BE CONFIRMED AND ROOT CAUSE COULD NOT BE DETERMINED.

    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 WHEN THE PUMP HAD AN OCCLUSION, IT MOSTLY OCCURRED DURING A CASSETTE CHANGE, AFTER ONE CASSETTE HAD FINISHED AND A NEW ONE WAS INSERTED. IN ADDITION TO THE MAIN PROBLEM, IT WAS ALSO STATED THAT THIS HAS HAPPENED WITH SEVERAL 250 ML CASSETTES (LOT 6070562) AND SEVERAL SOLIS HPCA PUMPS. EVENT OCCURRED AT A HOSPITAL AND WAS WHILE USED IN PATIENT, ALSO NO HARM HAPPENED AS RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    25630 CADD MEDICATION CASSETTE RESERVOIR SET, ADMINISTRATION, INTRAVASCULAR FPA ICU MEDICAL, INC 7309 6070562 10610586032387

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown