BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IVENIX, INC.

    MDR report key: 22194150 · Received June 12, 2025

    Report

    Report Number
    22194150
    Event Type
    Malfunction
    Date Received
    June 12, 2025
    Date of Event
    May 21, 2025
    Report Date
    May 21, 2025
    Manufacturer
    FRESENIUS KABI AG
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    MULTIPLE TUBING FAILURES BETWEEN AN APPROXIMATE 3-WEEK PERIOD FROM [REDACTED TO REDACTED]: QUANTITY 7 OF SET-0014-1, LOT FA24105127- 2 WOULDN'T BACK-PRIME, 5 TUBING SET ALARM. QUANTITY 1 OF SET-0021-1, LOT UNKNOWN- TUBING SET ALARM. QUANTITY 22 OF SET-0032-1, LOTS: FA23K03171: 1 WON'T BACK-PRIME, FA24J07013: 1 LEAKING CASSETTE, FA24J14027: 1 LEAKING Y SITE, 1 ROTATING LUER LOCK BROKE, FA24J21253: 1 LEAKING CASSETTE, FA24K05015: 1 LEAKING CASSETTE, FA24KO1162: 1 LEAKING CASSETTE, FA25A27143: 1 BROKE AT DISTAL Y SITE, FA25A28018: 2 LEAKING CASSETTE, 1 TUBING SET ALARM, FA25B24023: 1 BROKE AT CONNECTOR, UNKNOWN LOTS: 1 BROKE AT CONNECTOR, 3 BROKE AT DISTAL Y SITE, 5 LEAKING CASSETTE, 1 TUBING BACK FLOW. SPREADSHEET SAVED IN SAFETY TEAMS, EQUIPMENT, MEDSUN. MANUFACTURER RESPONSE FOR SET, ADMINISTRATION, INTRAVASCULAR, IVENIX INFUSION SYSTEM (PER SITE REPORTER). WORKING WITH MFG. MANUFACTURER RESPONSE FOR SET, ADMINISTRATION, INTRAVASCULAR, IVENIX, INC. (PER SITE REPORTER). WORKING WITH MFG. MANUFACTURER RESPONSE FOR SET, ADMINISTRATION, INTRAVASCULAR, IVENIX, INC. (PER SITE REPORTER) WORKING WITH MFG.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1806558 IVENIX, INC. SET, ADMINISTRATION, INTRAVASCULAR FPA FRESENIUS KABI AG SET-0021-1 FA24105127

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown