BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IVENIX, INC.

    MDR report key: 22851526 · Received August 20, 2025

    Report

    Report Number
    22851526
    Event Type
    Malfunction
    Date Received
    August 20, 2025
    Date of Event
    June 6, 2025
    Report Date
    June 6, 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

    49 IVENIX IV TUBING FAILURES REPORTED FROM [REDACTED DATES], AN APPROXIMATE 1-MONTH PERIOD. SET-0014-1- (2 SETS) - LOT FA24K05015, ALARM: TUBING PROBLEM, WOULD NOT BACK-PRIME. SET-0021-1- (3 SETS) - LOT FA25C2?- 2- TUBING DISCONNECTED, 1-LEAKING CASSETTE. SET-0032-1- (44 SETS) - LOT FA24J28027- 1 LEAKING CASSETTE. LOT- FA24G29048 - 1 - ADDITIONAL LUER LOCK, MISSING VENT, DRIP CHAMBER, AND SPIKE. LOT - FA24J03145 - 1 TUBING DISCONNECTED. LOT - FA24J21253 - 2 SETS - LEAKING CASSETTE, 1- WOULD NOT BACK PRIME. LOT - FA24J28035 - 2 SETS LEAKING CASSETTE. LOT- FA25A27135 - 1 ALARM: TUBING PROBLEM, 6 LEAKING CASSETTES, 2 TUBING DISCONNECTED, 2 NO BACK PRIMING. LOT - UNKNOWN - 1 ALARM: CASSETTE ERROR, 1 BACKFLOWING, 1 COLLAPSING DRIP CHAMBER, 7 LEAKING CASSETTES, 1 TUBING DISCONNECTED, 14 CRACKED/LEAKING TUBING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1144406 IVENIX, INC. SET, ADMINISTRATION, INTRAVASCULAR FPA FRESENIUS KABI AG SET-0014-1 FA24K05015

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown