BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IVENIX LARGE VOLUME INFUSION PUMP

    MDR report key: 18992978 · Received March 28, 2024

    Report

    Report Number
    3014732157-2024-00128
    Event Type
    Malfunction
    Date Received
    March 28, 2024
    Date of Event
    February 27, 2024
    Report Date
    July 18, 2024
    Manufacturer
    FRESENIUS KABI USA, LLC
    Product Code
    FRN
    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

    THE COMPLAINT WAS FLAGGED FOR HAVING ISSUES LOADING TESTING CASSETTES. THE INITIAL TECHNICAL FAILURE WAS ATTRIBUTED TO A MECHANICAL HARDWARE FAILURE (AV ASSEMBLY). LOGS WERE PULLED FROM THE PUMP, AND IT WAS CONFIRMED THAT THE PUMP WAS EXPERIENCING FAILURES ACCEPTING TESTING CASSETTES. WHILE THE PUMP WAS IN THE DECONTAMINATION/RETURN PROCESS; IT WAS NOTED THAT THE PUMP WAS EXCESSIVELY DIRTY AND REQUIRED EXTRA CLEANING TO CONFORM TO THE DECONTAMINATION/CLEANING STANDARDS. DURING TESTING, THE PUMP WAS ABLE TO LOAD TESTING CASSETTES WITH NO ERROR MESSAGES AND WAS ABLE TO PASS A FINAL ACCEPTANCE TEST WITH NO FAILURES. THE PUMP WAS OPENED, AND AN INTERNAL INVESTIGATION WAS PERFORMED AND FOUND THE FVA VALVE PINS AND LOADING PINS TO HAVE TRACES OF FOREIGN MATERIAL ON THE MOVING SURFACES. IT IS BELIEVED THAT THE EXTRA EXTENSIVE CLEANING OF THE PUMP WAS ABLE TO FREE UP THE FVA PINS SO THAT THE PUMP WAS ABLE TO FUNCTION PROPERLY DURING TESTING. THE FVA PIN LIP SEALS AND LOADING PIN LIP SEALS WILL BE REPLACED TO ENSURE OVERALL FUNCTIONALITY AND THEN THE PUMP WILL UNDERGO ALL NECESSARY FUNCTIONAL TESTING TO ENSURE RELIABILITY. ONCE THE PUMP HAS SUCCESSFULLY PASSED ALL NECESSARY FUNCTIONAL TESTING, IT WILL BE REVIEWED FOR QUALITY RELEASE.

    Description of Event or Problem · 0

    THE FOLLOWING HAS BEEN REPORTED: BIOMED REPORTS: THIS GUY (PUMP) DOESN'T SEEM HAPPY ABOUT LOADING TUBE SETS. IT IS CLEAN, THE PINS ARE MOVING FREELY AND ARE WHERE THEY ARE SUPPOSED TO BE. NO MENTION OF PT HARM OR INFUSION STOPPAGE. AN INITIAL REVIEW OF THE DEVICE LOGS REVEALS THE FOLLOWING: MECHANICAL HARDWARE FAILURE (AV ASSEMBLY) AN ACTIVE INFUSION WAS NOT DELAYED (PER THE LOGS); NO ADVERSE EVENT WAS COMMUNICATED. REPORTING DUE TO THE REFERENCED ISSUE AS A CONSERVATIVE MEASURE. FURTHER INFORMATION IS NEEDED TO COMPLETE THE INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    910202 IVENIX LARGE VOLUME INFUSION PUMP INFUSION PUMP SYSTEM FRN FRESENIUS KABI USA, LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown