BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CADD MEDICATION CASSETTE

    MDR report key: 21922830 · Received April 28, 2025

    Report

    Report Number
    3012307300-2025-04933
    Event Type
    Malfunction
    Date Received
    April 28, 2025
    Date of Event
    March 1, 2025
    Report Date
    September 10, 2025
    Manufacturer
    SMITHS HEALTHCARE MANUFACTURING S.A. DE C.V.
    Product Code
    FPA
    UDI-DI
    10610586032370
    PMA / PMN Number
    K081156
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    E1 - INITIAL REPORTER PHONE: (B)(6). B3: DATE OF EVENT IS UNKNOWN; NO INFORMATION HAS BEEN PROVIDED TO DATE. H3: DEVICE NOT RETURNED TO MANUFACTURER. 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 REPORTABLE INFORMATION BECOMES AVAILABLE.

    Additional Manufacturer Narrative · 0

    THE DEVICE HISTORY RECORD OF REPORTED LOT 6061516 WAS REVIEWED, AND IT WAS CONFIRMED THAT NO NON-CONFORMITIES WERE REPORTED DURING PRODUCTION. THE QUALITY INSPECTION FORMS WERE REVIEWED, AND IT WAS OBSERVED THAT NO DEFECTS WERE FOUND, AND THE LOT WAS RELEASED. WITHOUT THE RETURN OF THE SAMPLES A COMPREHENSIVE FAILURE INVESTIGATION CANNOT BE PERFORMED, AND A PROBABLE CAUSE CANNOT BE DETERMINED. IF THE PRODUCT IS RETURNED, THE COMPLAINT WILL BE REOPENED FOR FURTHER INVESTIGATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE CADD PUMP DISPLAYS ERROR MESSAGE "DOWNSTREAM OCCLUSION. CLEAR OCCLUSION BETWEEN PUMP AND PATIENT". THE CASSETTES WERE TESTED IN THE PHARMACY CLEANROOM WITH "NS 0.9%" AND WORKED CORRECTLY. NO INJURY TO THE PATIENT WAS CAUSED BY THE PRODUCT ISSUE. HOWEVER, PATIENTS HAD TO WAIT AN ADDITIONAL 15-30 MINUTES WHILE A NEW CASSETTE WAS BEING COMPOUNDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    484027 CADD MEDICATION CASSETTE SET, ADMINISTRATION, INTRAVASCULAR FPA SMITHS HEALTHCARE MANUFACTURING S.A. DE C.V. 6061516 10610586032370

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown