BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IVENIX, INC.

    MDR report key: 20446786 · Received October 14, 2024

    Report

    Report Number
    3014732157-2024-00756
    Event Type
    Injury
    Date Received
    October 14, 2024
    Date of Event
    October 3, 2024
    Report Date
    November 22, 2024
    Manufacturer
    FRESENIUS KABI USA, LLC
    Product Code
    FPA
    UDI-DI
    00811505030054
    PMA / PMN Number
    K183311
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    N/A

    Description of Event or Problem · 0

    THE FOLLOWING HAS BEEN REPORTED: DESCRIPTION OF INCIDENT FROM USER: 0.9%NS INFUSING VIA GRAVITY ON IVENIX ADMINISTRATION SET 001325. REMIFENTANIL GTT INFUSING VIA BD ALARIS PUMP INFUSION SET AND PROPOFOL GTT INFUSING ON A SEPARATE BD ALARIS PUMP INFUSION SET AND ATTACHED AT THE LOWER Y-SITE OF THE IVENIX ADMINISTRATION SET. REMIFENTANIL GTT AND PROPOFOL GTT REMOVED FROM ALARIS PUMP. ONCE REMIFENTANIL GTT AND PROPOFOL GTT REMOVED FROM ALARIS PUMP REMIFENTANIL AND PROPOFOL BEGAN TO BACKFLOW INTO THE IVENIX PRIMARY ADMINISTRATION SET AND INTO THE 0.9%NS BAG THAT WAS HUNG ON THE IVENIX ADMINISTRATION SET. PATIENT BEGAN TO WAKE UP WHILE ON OR TABLE. ONCE CLINICIAN NOTICED PATIENT WAS NOT RECEIVING INFUSIONS BEGAN TO INFUSE AGAIN VIA ALARIS PUMP. NO PATIENT HARM . FRESENIUS KABI HAS REQUESTED FEEDBACK REGARDING THIS COMPLAINT FROM THE CUSTOMER: WHERE WAS THE NS BAG HANGING IN RELATION TO THE ADMINISTRATION SITE (I.E. ABOVE, SAME LEVEL, BELOW)? ABOVE WHERE WAS THE IV LOCATED THAT WAS BEING USED TO DELIVER THE INFUSATE? RIGHT HAND WERE THERE ANY ISSUES NOTED WITH THE IV SITE (EXTRAVASATION, INFILTRATION, LOOSE CONNECTIONS ETC.)? NO WAS THE IV ABLE TO FLUSH WITH BLOOD RETURN CONFIRMED? (NO ANSWER) DID THE PATIENT HAVE A HIGH BP OR WAS RECEIVING ANY MEDICATIONS THAT WOULD VASOCONSTRICT AND ENCOURAGE BACKFLOW? NOT TO [REPORTER'S] KNOWLEDGE. WAS A BACKCHECK VALVE BEING USED? NO HOW LONG DID IT TAKE FOR THE MEDICATION TO BACKFLOW AND REACH THE BAG OF NS? (NO ANSWER) A PRELIMINARY REVIEW OF THE INFORMATION WAS PERFORMED BY FRESENIUS KABI. IT HAS BEEN ASSESSED AS A BACKFLOW SITUATION OCCURRING - UNDERINFUSION. THIS DID NOT OCCUR DURING AN ACTIVE INFUSION. REPORTING AS A CONSERVATIVE MEASURE; WHILE NO INJURY WAS REPORTED, THE PATIENT WAS NOT RECEIVING INFUSIONS WHEN THE MEDICATION WAS REMOVED FROM THE BD ALARIS PUMP AND BEGAN TO WAKE UP DURING THE PROCEDURE. NOTE THAT THE IVENIX SET WAS BEING USED AS AN EXTENSION UNDER GRAVITY BUT DOES NOT CONTAIN A BACKCHECK VALVE PER FRESENIUS KABI CLINICAL. ADDITIONAL INFORMATION IS NEEDED TO COMPLETE THE INVESTIGATION.

    Description of Event or Problem · 0

    NO SAMPLE OR PICTURE WAS AVAILABLE FOR ANALYSIS. THE CUSTOMER REPORTED ISSUE COULD NOT BE CONFIRMED. THE POSSIBLE BACKFLOW MAY HAVE OCCURRED WHEN THE CLINICIAN REMOVED THE REMIFENTANIL AND PROPOFOL INFUSIONS FROM THE ALARIS PUMP. IF THESE SOLUTIONS WERE THEN PLACED BELOW THE SOLUTION BAG, OR SIGNIFICANTLY BELOW THE PATIENT'S POSITION, GRAVITY COULD HAVE CAUSED THE SOLUTIONS TO FLOW BACK INTO THE BAG. HOWEVER, A SAMPLE OR ADDITIONAL EVIDENCE AND INFORMATION IS NEEDED IN ORDER TO DETERMINE THE EXACT ROOT CAUSE. CURRENT PROCESS CONTROLS INCLUDE 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. A 100% VISUAL INSPECTION IS PERFORMED IN MANUFACTURING LINE. THE AFFECTED BATCH WAS NOT PROVIDED BY THE CUSTOMER, THEREFORE, BATCH REVIEW COULD NOT BE PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2231564 IVENIX, INC. LVP PRIMARY ADMINISTRATION SET, DUAL-INLET, LOW-SORBING, NEEDLE-FREE PORT,Y-SITE FPA FRESENIUS KABI USA, LLC SET-0013-1 00811505030054

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown