BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IVENIX, INC.

    MDR report key: 19953805 · Received August 9, 2024

    Report

    Report Number
    3014732157-2024-00561
    Event Type
    Malfunction
    Date Received
    August 9, 2024
    Date of Event
    July 30, 2024
    Report Date
    October 16, 2024
    Manufacturer
    FRESENIUS KABI USA, LLC
    Product Code
    FPA
    UDI-DI
    00811505030054
    PMA / PMN Number
    K183311
    Removal / Correction Number
    3014732157-08/02/24-001-
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, 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

    REPORTED TO FRESENIUS KABI: CUSTOMER REPORTED: ON (B)(6) 2024 AROUND 500PM PUMP ALARM NO PT HARM. ISSUE OCCURRED WHILE USING LVP-0004 S/N: (B)(6). A PRELIMINARY REVIEW OF THE DEVICE LOGS INDICATES THE FOLLOWING: OVER INFUSION CONDITION (SAFE STATE 1) (SET ISSUE) SAFE STATE 1 ALARM PREVENTS USER FROM BEING ABLE TO KEEP USING THE PUMP SAFE STATE 1 KEEPS THE RED LEDS FLASHING, AND THE ALARM KEEPS RETURNING AFTER SOME TIME AFTER BEING ACKNOWLEDGED UNLESS THE PUMP IS POWERED DOWN FULLY. FRESENIUS KABI HAS AN ACTIVE INVESTIGATION OPENED TO REVIEW THE ISSUE WHICH WAS FURTHER ESCALATED BY RECALLING A SINGLE IDENTIFIED LOT# OF THE ADMINISTRATION SET, WHICH WAS REPORTED TO THE FDA VIA A FIELD CORRECTIVE ACTION ON AUGUST 2, 2024. ADDITIONAL INFORMATION IS NEEDED TO COMPLETE THE INVESTIGATION.

    Description of Event or Problem · 0

    NO PRODUCT WAS RETURNED AND NO LOT NUMBER WAS PROVIDED FOR EVALUATION. A CAPA WAS OPENED TO INVESTIGATE THE OVERINFUSION ALARMS AND A MANUFACTURING DEFECT FOR A SINGLE LOT WAS IDENTIFIED WHICH ALLOWED AN INTERNAL LEAK FROM ONE PORTION OF THE FLUID PATH TO ANOTHER. THE LOCATION OF THE LEAK BYPASSES THE FLUIDIC RESISTOR, AND THEREFORE THE "FLOW DIAL" IS UNABLE TO STOP THE FLOW OF FLUID WHEN OUTSIDE OF THE PUMP. THE LEAK RESULTS IN THE PUMP DECLARING ONE OF THE FOLLOWING 2 ALARMS: - A "PUMP PROBLEM" FAIL-STOP ALARM (DUE TO OVER-INFUSION DETECTED BY CONTROL SYSTEM DURING INFUSION) - A "TUBING SET PROBLEM" FAIL-STOP ALARM (DUE TO A LEAK DETECTED BY CONTROL SYSTEM DURING INFUSION) WHEN THE PUMP PROBLEM ALARM IS DECLARED, THE USER IS PROMPTED TO REMOVE THE ADMINISTRATION SET. IF THE USER EJECTS THE SET WITHOUT A SLIDE CLAMP ENGAGED THE LEAKAGE WILL CONTINUE. IF THE SET IS CONNECTED TO A PATIENT AT THE TIME, THE INFUSATE WILL CONTINUE TO BE DELIVERED TO THE PATIENT. THE INVESTIGATION WAS ABLE TO CONFIRM THAT A SINGLE LOT WAS AFFECTED DUE TO THIS MANUFACTURING DEFECT AS THE NEST ALIGNMENT ISSUE WAS ADDRESSED BEFORE THE PRODUCTION START OF THE NEXT LOT. THE MOST LIKELY ROOT CAUSE IDENTIFIED IS: INADEQUATE NEST LEVELING INSTALLATION CARRIED OUT AT CONTRACT MANUFACTURING SITE WHICH RESULTED IN A DEGRADED WELD QUALITY. ACTION PLANS HAVE BEEN DEVELOPED TO ENSURE PROPER NEST ALIGNMENT AND VERIFICATION VIA PROCEDURAL AND RMF UPDATES, TRAINING AND UPDATED LEAK TESTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2514823 IVENIX, INC. ADMINISTRATION SET FPA FRESENIUS KABI USA, LLC SET-0013-1 00811505030054

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown