BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IVENIX INFUSION SYSTEM

    MDR report key: 19696932 · Received July 8, 2024

    Report

    Report Number
    3014732157-2024-00467
    Event Type
    Malfunction
    Date Received
    July 8, 2024
    Date of Event
    June 17, 2024
    Report Date
    October 11, 2024
    Manufacturer
    FRESENIUS KABI USA, LLC
    Product Code
    FRN
    UDI-DI
    00811505030320
    PMA / PMN Number
    K183311
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    N/A.

    Description of Event or Problem · 0

    DUE DILIGENCE HAS BEEN COMPLETED FOR THIS COMPLAINT. AS OF THE DATE OF THIS REPORT, THE DEVICE HAS NOT BEEN RECEIVED FOR FURTHER INVESTIGATION. THIS INVESTIGATION SHALL BE CLOSED AND IF THIS DEVICE BECOMES AVAILABLE IN THE FUTURE THE COMPLAINT WILL BE RE-OPENED AND AN EVALUATION SHALL BE PERFORMED.

    Description of Event or Problem · 0

    THE FOLLOWING HAS BEEN REPORTED: NURSE REPORTED TO STAFF: LAST NIGHT I HAD A PATIENT THAT I STARTED TWO DIFFERENT IV DRIPS WITH 2 DIFFERENT PUMPS, AT THE SAME TIME. THE PICTURED FLAGYL DRIP WAS PROGRAMMED TO RUN OVER 60 MINUTES, AND THE OTHER DRIP WAS PROGRAMMED TO RUN OVER 30 MINUTES. WHEN THE 30 MIN DRIP ALARMED THAT IT WAS FINISHED, I WENT INTO THE PATIENT'S ROOM TO DC THE DRIP AND FLUSH THE LINE. WHEN I WALKED INTO THE ROOM, THE IV PUMP RUNNING FLAGYL WAS FROZEN, AND THE RED LIGHT ON TOP WAS FLASHING. IT WAS NOT EMITTING ANY SORT OF AUDIBLE ALARM. THE IV PUMP WAS COMPLETELY FROZEN AND WOULD NOT ALLOW ME TO UNLOCK THE SCREEN OR DO ANYTHING TO IT. THE MOST CONCERNING PART IS THAT THE BAG OF FLAGYL IV FLUID WAS COMPLETELY EMPTY. IN SUMMARY, THE IV PUMP HAD FROZEN 13 MINUTES INTO THE INFUSION, AND FREE-FLOWED THE ENTIRE BAG OF FLAGYL INTO THE PATIENT. THE PATIENT HAD NO CHANGES IN VITAL SIGNS AND NO APPARENT HARM WAS DONE. HOWEVER, IF THIS HAD BEEN AN INFUSION OF INSULIN, HEPARIN, DILTIAZIM, LEVOPHED, OR ANY NUMBER OF OTHER MEDICATIONS WE FREQUENTLY USE IN THE ER, IT MOST PROBABLY WOULD HAVE RESULTED IN A SENTINEL EVENT. COULD YOU PLEASE PASS THIS ON TO WHOMEVER MANAGES THE IV PUMPS, AND HAVE THIS LOOKED INTO? I REPORTED THIS TO BRANDON, OUR CHARGE NURSE LAST NIGHT, AND HE IS PLACING A MIDAS. PLEASE LET ME KNOW IF YOU NEED ANY OTHER INFORMATION. REACHED OUT TO STAFF TWICE TO GET SERIAL # AND LOGS FROM PUMP. A PRELIMINARY REVIEW OF THE LOGS IDENTIFIED THE FOLLOWING ISSUE: OVERDOSE AND FROZEN PUMP AN ACTIVE INFUSION NOT 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
    142700 IVENIX INFUSION SYSTEM LARGE VOLUME PUMP (LVP) FRN FRESENIUS KABI USA, LLC LVP-0004 00811505030320

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown