BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CADD MEDICATION CASSETTE RESERVOIR

    MDR report key: 23347449 · Received October 21, 2025

    Report

    Report Number
    3012307300-2025-11580
    Event Type
    Malfunction
    Date Received
    October 21, 2025
    Date of Event
    September 17, 2025
    Report Date
    October 21, 2025
    Manufacturer
    ICU MEDICAL HEALTHCARE MANUFACTURING S.A. DE C.V.
    Product Code
    FPA
    PMA / PMN Number
    K040636
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    D4 - LOT #: POSSIBLE NUMBERS 6101812, 6085508 AND 6085510. H3: NO DEVICE WAS RETURNED BUT TWO PHOTOS AND TWO VIDEOS WERE ATTACHED TO THE COMPLAINT. IN THE VIDEOS AND PHOTOS, A PARTICULATE WAS DETECTED INSIDE OF THE FLUID PATH. ACCORDING TO PHOTO AND VIDEO RECEIVED, THE FAILURE MODE ¿A0226 - PARTICULATE INSIDE THE FLUID PATH¿ WAS CONFIRMED. WITHOUT THE RETURN OF THE PRODUCT A COMPREHENSIVE FAILURE INVESTIGATION CANNOT BE PERFORMED, AND A PROBABLE CAUSE CANNOT BE DETERMINED. IF THE PRODUCT IS RETURNED, THE MANUFACTURER WILL REOPEN THIS COMPLAINT FOR FURTHER INVESTIGATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING PRODUCTION USING THE 50 ML GRAY CADD CASSETTES (PN 21-7301-24), A PARTICLE WAS IDENTIFIED IN ONE UNIT THROUGH 100% VISUAL INSPECTION. THE MAJORITY OF THE CASSETTES USED WERE FROM LOT# 6101812. HOWEVER, SINCE UNITS FROM OTHER LOTS WERE ALSO UTILIZED DURING THE PROCESS, IT IS NOT POSSIBLE TO ATTRIBUTE THE ISSUE TO A SINGLE LOT. NOTABLY, LOT# 6085510 HAS PREVIOUSLY BEEN ASSOCIATED WITH SIMILAR COMPLAINTS ((B)(4)). THE PARTICLES HAD BEEN DESCRIBED BY STAFF AS ¿OPAQUE, WHITE AND ROUNDISH, SIMILAR TO THOSE WE HAVE BEEN SEEING.¿ PICTURES AND VIDEOS WERE PROVIDED. THERE WAS NO REPORTED PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    879225 CADD MEDICATION CASSETTE RESERVOIR SET, ADMINISTRATION, INTRAVASCULAR FPA ICU MEDICAL HEALTHCARE MANUFACTURING S.A. DE C.V. 7300 NI

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown