BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDEX C FUSOR 500ML PRESSURE INFUSOR

    MDR report key: 20739758 · Received November 20, 2024

    Report

    Report Number
    1526863-2024-00093
    Event Type
    Malfunction
    Date Received
    November 20, 2024
    Date of Event
    July 1, 2024
    Report Date
    November 20, 2024
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    KZD
    UDI-DI
    50351688507011
    PMA / PMN Number
    UNKNOWN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    B3. DATE OF EVENT: UNKNOWN. NO INFORMATION HAS BEEN PROVIDED TO DATE. INVESTIGATION SUMMARY: PRODUCT TOTALING EIGHT UNITS RECEIVED FOR INVESTIGATION IN ORIGINAL PACKAGING AND APPEARED TO BE IN UNUSED CONDITION. NO TESTING PERFORMED. PERFORMED VISUAL EVALUATION AND COMPARISON OF THE LOT NUMBER ON THE BOX LABEL AND LOT NUMBER PRINTED ON THE ASSEMBLIES. FINISHED ASSEMBLY ARE IDENTIFIED AS REQUIRED WITH LOT NUMBER TRACEABILITY, NO PROBLEM IDENTIFIED. COMPLETED ASSEMBLY OF THE FINISHED DEVICE AS A MX4805P1 OCCURRED IN ANOTHER ICU MEDICAL LOCATION IN THE EUROPEAN UNION WHERE THE PRODUCT WAS CE MARKED. THE FINISHED ASSEMBLY WAS PRODUCED FROM SUBASSEMBLIES PROVIDED FROM THE DUBLIN, OHIO MANUFACTURING SITE. THESE SUBASSEMBLIES HAVE THEIR OWN LOT NUMBER IDENTIFICATION APPLIED DURING PRODUCTION. THE PRODUCT WAS PULLED FROM THE EU MARKET AS PART OF A CE RE-CLASSIFICATION PROJECT WITH ALL REMAINING INVENTORY FROM THE DISTRIBUTION CENTER SENT BACK TO THE DUBLIN, OHIO MANUFACTURING SITE TO BE REPACKAGED AS MX4805 PER APPROVED PROCEDURE AND ADDED INTO DUBLIN MANUFACTURING INVENTORY. NO ACTIONS ARE BEING IMPLEMENTED AS THE FINISHED ASSEMBLY ARE IDENTIFIED AS REQUIRED, NO PROBLEM IDENTIFIED. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) SHOWS THERE WERE NO OBSERVATIONS OR NONCONFORMITIES RECORDED DURING MANUFACTURE TO SUGGEST AN ISSUE OF THIS NATURE WOULD OCCUR WITH THIS LOT OF PRODUCTS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THERE WAS A DISCREPANCY BETWEEN THE LOT NUMBERS PRINTED ON THE LABELS AND THOSE ON THE ACTUAL PRODUCTS. THE LOT NUMBER ON THE BOX WAS 6015735 AND THE LOT NUMBER ON THE PRODUCT WAS 4262848. THERE WAS NO PATIENT INVOLVEMENT, AND NO PATIENT HARM/ADVERSE EVENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2459611 MEDEX C FUSOR 500ML PRESSURE INFUSOR INFUSOR, PRESSURE, FOR IV BAGS KZD SMITHS MEDICAL ASD, INC. 6015735 50351688507011

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown