BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IVENIX, INC.

    MDR report key: 20577944 · Received October 31, 2024

    Report

    Report Number
    3014732157-2024-00789
    Event Type
    Malfunction
    Date Received
    October 31, 2024
    Date of Event
    October 10, 2024
    Report Date
    January 28, 2025
    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

    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 REPORTED: WHEN REPRIMING THE TUBING, THE CASSETTE NOT WORKING. COULD NOT DUPLICATE CLEANED PINS, RUN TEST PATIENT WITHOUT ISSUE. RETURNED TO SERVICE. A PRELIMINARY REVIEW IDENTIFIED THE FOLLOWING ISSUE: SET NOT WORKING. UNKNOWN IF AN ACTIVE INFUSION WAS STOPPED. REPORTING AS A CONSERVATIVE REPORT FOR THE CASSETTE NOT WORKING, BUT WE DO NOT HAVE ANY ADDITIONAL INFORMATION AT THIS TIME. NO ADVERSE EFFECTS WERE REPORTED. ADDITIONAL INFORMATION IS NEEDED TO COMPLETE THE INVESTIGATION.

    Description of Event or Problem · 0

    FRESENIUS KABI REQUESTED FOLLOW UP 3 TIMES FOR ADDITIONAL INFO AND THE ANSWERS WERE NOT PROVIDED. THE PUMP PROBLEM IS UNKNOWN. DUE DILIGENCE HAS BEEN COMPLETED WITH NO RESPONSE. BIOMED EMAILED SERIAL # (B)(6), REPORTED: CASSETTE NOT WORKING. COULD NOT DUPLICATE CLEANED PINS, RUN TEST PATIENT WITHOUT ISSUE, RETURNED TO SERVICE. CASSETTE ADMIN SET NOT WORKING- NO ADDITIONAL INFORMATION PROVIDED. A DHR REVIEW OF SERIAL NUMBER (B)(6) WAS CONDUCTED AND NO RELATED MANUFACTURING NONCONFORMANCE RECORDS WERE FOUND. THERE WERE NO OTHER INCIDENTS IN PRODUCTION OF THIS PRODUCT THAT WOULD HAVE CAUSED THE REPORTED ISSUE. WITH NO ADDITIONAL INFORMATION REGARDING THE CASSETTE OR THE FAILURE THAT WAS EXPERIENCED, NO FURTHER INVESTIGATION CAN BE PERFORMED. THE COMPLAINT WILL BE CLOSED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1804571 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