BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CADD ADMINISTRATION SET

    MDR report key: 22413258 · Received July 7, 2025

    Report

    Report Number
    3012307300-2025-07953
    Event Type
    Malfunction
    Date Received
    July 7, 2025
    Date of Event
    June 9, 2025
    Report Date
    July 7, 2025
    Manufacturer
    SMITHS HEALTHCARE MANUFACTURING S.A. DE C.V.
    Product Code
    FRN
    UDI-DI
    10610586029646
    PMA / PMN Number
    K040636
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    D4 - LOT #: POSSIBLE LOTS 6061452, 6071181. H3: NO PRODUCT WAS RECEIVED FOR ANALYSIS. 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. THE SERVICE HISTORY REVIEW HAD NO INDICATION THAT THE COMPLAINT WAS RELATED TO A SERVICE OF THE DEVICE WITHIN THE REVIEW PERIOD.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DEVICE UNDER DELIVERED. PER REPORTER THE DEVICE ALARMED "INFUSION COMPLETE OR EMPTY", HOWEVER, THE PATIENT DID NOT RECEIVE THE ENTIRE MEDICATION/BAG. THE PUMP INDICATED THAT INFUSION WAS COMPLETE BUT THERE WAS DEFINITELY AT LEAST 100 ML LEFT IN BAG. A CONTINUOUS INFUSION RATE OF 6 ML/HOUR HAD BEEN PROGRAMMED, WITH A TOTAL RESERVOIR VOLUME OF 275 ML AND GIVEN 275 ML BUT THERE WAS STILL AT LEAST 100 ML IN THE BAG. THE AIR DETECTOR AND UPSTREAM SENSOR HAD BEEN TURNED OFF. THE LENGTH OF INFUSION HAD BEEN SET TO 46 HOURS, AND THE LOCK LEVEL HAD BEEN SET TO LL2. A CLOSED SYSTEM DRUG TRANSFER DEVICE (CSTD) WAS USED TO FILL CASSETTE. THERE WAS PATIENT INVOLVEMENT, BUT NO PATIENT HARM REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2767260 CADD ADMINISTRATION SET PUMP, INFUSION FRN SMITHS HEALTHCARE MANUFACTURING S.A. DE C.V. 7300 NI 10610586029646

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown