BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IVENIX INFUSION SYSTEM

    MDR report key: 21709817 · Received March 27, 2025

    Report

    Report Number
    3014732157-2025-00218
    Event Type
    Malfunction
    Date Received
    March 27, 2025
    Date of Event
    March 7, 2025
    Report Date
    May 12, 2025
    Manufacturer
    FRESENIUS KABI USA LLC
    Product Code
    FPA
    PMA / PMN Number
    K183311
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    THE FOLLOWING HAS BEEN REPORTED: NURSE REPORTED: THE SPIKE WAS BROKEN. SET CODE/LOT ARE UNKNOWN. CUSTOMER DID NOT MENTION IF THERE WAS PATIENT INVOLVEMENT OR IF AN ACTIVE INFUSION WAS STOPPED DUE TO THE ABOVE INCIDENT. CUSTOMER STATED THE SET CONTAINS HAZARDOUS MATERIAL SO NO SAMPLE IS AVAILABLE FOR EVALUATION. EMAILED CUSTOMER ON 3/10/2025 FOR ADDITIONAL INFORMATION. PER EMAIL FROM (B)(6), FK REP, ON 3/10/2025 THIS IS THE ONLY INFORMATION THEY HAVE AVAILABLE; NO ADDITIONAL INFORMATION IS AVAILABLE. "ALTHOUGH A FRESENIUS KABI ADMINISTRATION SET WAS BEING USED, THE MODEL# OR LOT# WAS NOT DISCLOSED BY THE CUSTOMER." A PRELIMINARY REVIEW IDENTIFIED THE FOLLOWING ISSUE: ADMINISTRATION SET BREAKS (ANY PART). UNKNOWN IF ISSUE STOPPED AN ACTIVE INFUSION. REPORTING AS A CONSERVATIVE MEASURE. NO ADVERSE EFFECTS WERE REPORTED. ADDITIONAL INFORMATION IS NEEDED TO COMPLETE THE INVESTIGATION.

    Description of Event or Problem · 0

    NO SAMPLE OR PICTURE WAS AVAILABLE FOR ANALYSIS. WITHOUT THE PROPER SAMPLE OR PICTURE, AN EVALUATION IS NOT POSSIBLE TO DETERMINE THE PROBABLE ROOT CAUSE OF THE REPORTED FAILURE. THEREFORE, THE CUSTOMER COMPLAINT CANNOT BE CONFIRMED. PROBABLE ROOT CAUSE COULD BE RELATED TO IMPROPER HANDLING OF THE UNIT DURING THE PACKAGING PROCESS OR AT THE CUSTOMER FACILITY. THE CURRENT PROCESS CONTROLS DETECTION INCLUDES POST STERILIZATION SAMPLING FINAL INSPECTION. THE FIRST PIECE INSPECTION WILL BE PERFORMED TO THE FIRST FINAL ASSEMBLED KIT MANUFACTURED PER SHIFT. THIS KIT WILL BE SUBMITTED TO VISUAL INSPECTION AS PER THE CLASSIFICATION OF DEFECTS INCLUDED IN THIS SPECIFICATION AND AS PER THE APPLICABLE DRAWING. 100% VISUAL INSPECTION IS PERFORMED IN MANUFACTURING LINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1470835 IVENIX INFUSION SYSTEM SET, ADMINISTRATION, INTRAVASCULAR FPA FRESENIUS KABI USA LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown