BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IVENIX INC.

    MDR report key: 20322805 · Received September 27, 2024

    Report

    Report Number
    3014732157-2024-00698
    Event Type
    Malfunction
    Date Received
    September 27, 2024
    Date of Event
    September 4, 2024
    Report Date
    October 11, 2024
    Manufacturer
    FRESENIUS KABI USA LLC
    Product Code
    FPA
    UDI-DI
    00811505030030
    PMA / PMN Number
    K183311
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    NO SAMPLE OR PICTURE WAS AVAILABLE FOR ANALYSIS. WITHOUT THE PROPER SAMPLE OR PICTURE EVALUATION IT IS NOT POSSIBLE TO DETERMINE THE PROBABLE ROOT CAUSE OF THE REPORTED FAILURE. THEREFORE, THE CUSTOMER COMPLAINT CANNOT BE CONFIRMED. THE POSSIBLE ROOT CAUSE MAY BE RELATED TO 1) AN OCCLUSION IN THE CASSETTE PORT WHERE THE IV TUBE IS PLACED DUE TO EXCESS ADHESIVE (LOCTITE) APPLIED TO THE CONNECTION AND 2) LOCTITE DISPENSER EQUIPMENT FAILURE OR AN INCORRECT SETUP OF THIS EQUIPMENT. THE BATCH RECORDS FOR BATCH FA23K20371 WERE REVIEWED. NO EXCEPTIONS WERE GENERATED THAT COULD CLASSIFY AS A POSSIBLE ROOT CAUSE OF THIS DEFECT. THE FINISHED GOOD LOT HAS PASSED ALL SAMPLING ACCEPTANCE CRITERIA FOR ALL TESTS PERFORMED INCLUDING IN-PROCESS TESTING AND PRODUCT TESTING. THE CURRENT PROCESS CONTROLS DETECTION INCLUDE 1) 100% LEAK AND OCCLUSION TEST IS PERFORMED THROUGH THE LEAK AND OCCLUSION TEST MACHINE IN ORDER TO CAPTURE UNITS WITH ANY BLOCKAGE OR LEAK FAILURE MODE, 2) FINAL PHYSICAL INSPECTION RELATED TO OCCLUSIONS ON THE ADMIN SET AND 3) 100% VISUAL INSPECTION USING BLACK LIGHT, THE ASSOCIATE ENSURES THAT THE UV CURING ON THIS CASSETTE ASSEMBLY IS CORRECT.

    Description of Event or Problem · 0

    THE FOLLOWING HAS BEEN REPORTED: CUSTOMER REPORTED: BLOOD ADMINISTRATION TUBING SALINE BAG WAS SPIKED AND THE NURSES COULDN'T PRIME THE TUBING - SALINE STOPPED BEFORE CASSETTE AND COULDN'T GET IT TO ADVANCE. GRABBED A NEW SET OF TUBING AND THEN IT WORKED JUST FINE. WAITING FOR CONFIRMATION OF NO PATIENT HARM. A PRELIMINARY REVIEW OF THE LOGS IDENTIFIED THE FOLLOWING ISSUE: POTENTIAL BLOCKAGE AT THE SECONDARY PORT. UNKNOWN IF 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
    1611112 IVENIX INC. LVP BLOOD PRODUCTS ADMINISTRATION SET, DUAL-INLET, LOW-SORBING, YSITE, MESH FIL FPA FRESENIUS KABI USA LLC SET-0014-1 00811505030030

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown