BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IVENIX, INC.

    MDR report key: 20065681 · Received August 26, 2024

    Report

    Report Number
    3014732157-2024-00600
    Event Type
    Malfunction
    Date Received
    August 26, 2024
    Date of Event
    August 7, 2024
    Report Date
    October 11, 2024
    Manufacturer
    FRESENIUS KABI USA LLC
    Product Code
    FPA
    UDI-DI
    00811505030054
    PMA / PMN Number
    K183311
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    NO SAMPLE OR PICTURE WAS AVAILABLE FOR ANALYSIS. WITHOUT THE PROPER SAMPLE OR PICTURE EVALUATION IT IS NOT POSSIBLE TO DETERMINE THE PROBABLE ROOT CAUSE OF THE REPORTED FAILURE. THEREFORE, THE CUSTOMER COMPLAINT CANNOT BE CONFIRMED. POTENTIAL ROOT CAUSES INCLUDE 1) SMALL SYRINGES CAN SOMETIMES CAUSE THIS WHEN INFUSING FROM THE SECONDARY ACCESS PORT (THROUGH THE SECONDARY LAV) AND 2) OCCLUSIONS IN THE SET SUCH AS EXCESS OF ADHESIVE , KINKS OR CLAMPS BEING ACTUATED. HOWEVER, WITHOUT THE SAMPLE IS NOT POSSIBLE TO DETERMINE EXACT ROOT CAUSE.

    Description of Event or Problem · 0

    THE FOLLOWING HAS BEEN REPORTED: CUSTOMER REPORTED: PUMP: 2201811463. AUGUST 7 2024. WILL NOT BACK PRIME. TRIED OTHER TUBING, ISSUE PERSISTED. A PRELIMINARY REVIEW OF THE LOGS IDENTIFIED THE FOLLOWING ISSUE: BACKPRIME OCCLUSION ALERTS - NO PUMP MALFUNCTION IS ASSUMED. UNKNOWN IF AN ACTIVE INFUSION WAS STOPPED. REPORTING AS A CONSERVATIVE MEASURE. NO ADVERSE EFFECTS WERE REPORTED. ADDITIONAL INFORMATION IS NEEDED TO COMPLETE THE INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    269694 IVENIX, INC. LVP PRIMARY ADMINISTRATION SET, DUAL-INLET, LOW-SORBING, NEEDLE-FREE PORT, Y-SIT FPA FRESENIUS KABI USA LLC SET-0013-1 00811505030054

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown