BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IVENIX, INC.

    MDR report key: 20577628 · Received October 31, 2024

    Report

    Report Number
    3014732157-2024-00788
    Event Type
    Malfunction
    Date Received
    October 31, 2024
    Date of Event
    October 10, 2024
    Report Date
    November 25, 2024
    Manufacturer
    FRESENIUS KABI USA LLC
    Product Code
    FPA
    UDI-DI
    00811505030054
    PMA / PMN Number
    K183311
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    NO SAMPLE OR PICTURE WAS AVAILABLE FOR ANALYSIS. THE CUSTOMER REPORTED ISSUE COULD NOT BE CONFIRMED. ROOT CAUSE: UNABLE TO RE-PRIME IS POTENTIALLY RELATED TO OCCLUSIONS OR LEAKS IN THE ADMIN SET, CLAMPS BEING ACTUATED DURING THE PRIMING PROCESS OR KNOB BEING CLOSED. CURRENT PROCESS CONTROLS TO DETECT LEAKS 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) QUALITY SAMPLING FOR FINAL PHYSICAL TESTING, FOR PERFORMING A FLOW AND UNDERWATER LEAK TESTS, 3) 100% VISUAL INSPECTION DURING THE MANUFACTURING PROCESS AND FINAL PHYSICAL INSPECTIONS. THE AFFECTED BATCH WAS NOT PROVIDED BY THE CUSTOMER; THEREFORE, BATCH REVIEW COULD NOT BE PERFORMED.

    Description of Event or Problem · 0

    THE FOLLOWING HAS BEEN REPORTED: BIOMED REPORTED: THE CONCERN IS HOW OFTEN THE PUMP REQUIRES A COMPLETE SHUTDOWN TO CLEAR AN ALARM. IN THE 12 MONTHS RUNNING ON 5M/N WE NEVER HAD THIS MANY PUMPS PULLED FOR SERVICE OR "SERVICE ALARMS". LOOKING THROUGH WE HAVE ABOUT 24 PULLED RIGHT NOW. JUST LOOKING FOR SOME CLARIFICATION ON WHY WE DIDN'T SEE THIS ALARM PREVIOUSLY IN THE ORIGINAL 44 PUMPS. 10/16/24 - BIOMED SUPPLIED SERIAL #, REPORTED: WHEN REPRIMING THE TUBING, THE CASSETTE WILL NOT WORK, UNABLE TO DUPLICATE, CLEANED AND RUN TEST PATIENT WITHOUT ISSUE. RETURNED TO THE FLOOR. A PRELIMINARY REVIEW IDENTIFIED THE FOLLOWING ISSUE: UNABLE TO PRIME SET. 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
    2012261 IVENIX, INC. LVP PRIMARY ADMINISTRATION SET, DUAL-INLET, LOW-SORBING, NEEDLE-FREE PORT, Y-SIT FPA FRESENIUS KABI USA LLC SET-0013-1 00811505030054

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown