BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IVENIX INFUSION SYSTEM

    MDR report key: 20032291 · Received August 22, 2024

    Report

    Report Number
    3014732157-2024-00581
    Event Type
    Malfunction
    Date Received
    August 22, 2024
    Date of Event
    August 3, 2024
    Report Date
    October 14, 2024
    Manufacturer
    FRESENIUS KABI USA LLC
    Product Code
    FRN
    UDI-DI
    00811505030320
    PMA / PMN Number
    K183311
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    SECTIONS D1 AND D4 UPDATED TO ALIGN WITH THE INFORMATION LISTED ON GUDID.

    Description of Event or Problem · 0

    NO PRODUCT WAS RETURNED FOR INVESTIGATION. FRESENIUS KABI WAS IN COMMUNICATION WITH THE CUSTOMER, AND IT WAS FOUND THAT THE ISSUE WAS DUE TO CONTAMINATION CAUSING STICKING OF THE FVA VALVE PIN. THE ISSUE WAS RESOLVED WITH A THOROUGH CLEANING BY THE CUSTOMER. THE PUMP PASSED TEST INFUSIONS AND THE CUSTOMER PLACED THE UNIT BACK INTO ACTIVE SERVICE. FRESENIUS KABI HAS ALSO SENT A CLEANING LETTER WHICH CONTAINS A LINK TO TRAINING TOOLS THAT DOCUMENT THE PROPER CLEANING PROCESS FOR THE CASSETTE LOADING AREA OF THE PUMP.

    Description of Event or Problem · 0

    THE FOLLOWING HAS BEEN REPORTED: CUSTOMER REPORTED: PUMP: (B)(6) ON (B)(6) 2024. WE NEED TO CHECK FOR OVER INFUSION, SET ISSUES, AND PUMP ISSUES CASSETTE LOT# 3010943. PUMP PROBLEM RED FLASHING LIGHTS. PUMP WAS ACTIVELY INFUSING HEPARIN WHEN IT STARTED ALARMING. CLEANED PUMP, RAN TEST INFUSION, PASSED. PUMP RETURNED TO PATIENT USE. A PRELIMINARY REVIEW OF THE LOGS IDENTIFIED THE FOLLOWING ISSUE: MECHANICAL HARDWARE FAILURE. (AV STICKY VALVE) 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
    23690 IVENIX INFUSION SYSTEM LARGE VOLUME PUMP (LVP) FRN FRESENIUS KABI USA LLC LVP-0004 00811505030320

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown