BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CADD ADMINISTRATION SET

    MDR report key: 21826502 · Received April 11, 2025

    Report

    Report Number
    3012307300-2025-04210
    Event Type
    Malfunction
    Date Received
    April 11, 2025
    Date of Event
    March 17, 2025
    Report Date
    April 11, 2025
    Manufacturer
    SMITHS HEALTHCARE MANUFACTURING S.A. DE C.V.
    Product Code
    FPA
    PMA / PMN Number
    K031361
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    E1: FACILITY NAME (B)(6). H3: NEITHER SAMPLES NOR PICTURES WERE RECEIVED FOR THE ANALYSIS OF THIS COMPLAINT. THE DEVICE HISTORY RECORD OF REPORTED LOT NUMBER: 6082346 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE HYDRATION BAG WAS FOUND COMPLETELY FULL (2L) WHEN IT SHOULD HAVE BEEN INFUSING OVERNIGHT. THE PUMP HAD BEEN ON AND RUNNING, WITH THE RESERVOIR VOLUME DISPLAYING 166.4 ML, THEREBY INDICATING THAT THE PATIENT SHOULD HAVE RECEIVED 1834 ML. A CONTINUOUS INFUSION RATE OF 100 ML/HR HAD BEEN SET, WITH A TOTAL RESERVOIR VOLUME OF 2L WAS GIVEN ON (B)(6) 2025. THE PATIENT WAS MEDICALLY AFFECTED. THE PATIENT'S SYMPTOMS WERE NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1007673 CADD ADMINISTRATION SET SET, ADMINISTRATION, INTRAVASCULAR FPA SMITHS HEALTHCARE MANUFACTURING S.A. DE C.V. 6082346

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown