BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CADD

    MDR report key: 22193981 · Received June 12, 2025

    Report

    Report Number
    22193981
    Event Type
    Malfunction
    Date Received
    June 12, 2025
    Date of Event
    May 21, 2025
    Report Date
    May 29, 2025
    Manufacturer
    ICU MEDICAL, INC.
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    5FU CASSETTE MADE FOR PATIENT, NO OBVIOUS SIGNS OF MALFUNCTION/LEAK UPON COMPOUNDING (NO VISIBLE LEAKS IN IV COMPOUNDING HOOD, IN BAG CONTAINING MEDICATION PRE-ADMINISTRATION, OR UPON RN ADMINISTRATION). PUMP RAN ~45 MINUTES, THEN PATIENT RETURNED TO CANCER CENTER CITING LEAKING PUMP. UPON INVESTIGATION, CASSETTE WAS LEAKING ONTO BLACK CARRYING BAG, AND EVIDENCE OF LEAK VIA WHITE POWDER EVIDENT. SPILL KIT USED, PUMP AND CASSETTE SEQUESTERED, NEW CASSETTE COMPOUNDED FOR PATIENT USING A DIFFERENT LOT NUMBER CASSETTE. SWEEP OF PHARMACY REVEALED SEVERAL OTHER CASSETTES WITH SAME LOT NUMBER; THESE WERE IMMEDIATELY SEQUESTERED FROM REST OF STOCK. LOT NUMBER 6077770 OF THE 250 ML CASSETTE REF 21-7308-24. CADD EXTENSION SET (SMITHS MEDICAL): REF 21-7047-24. EXP 2029-10-23. LOT 6061868. CADD PUMP (SMITHS MEDICAL): REF 21-7308-24, EXP 2029-12-01, LOT 6077770.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2032908 CADD SET, ADMINISTRATION, INTRAVASCULAR FPA ICU MEDICAL, INC. 21-7047-24 6061868

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown