BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NIMBUS II FLEX AMBULATORY INFUSION PUMP

    MDR report key: 19267635 · Received May 8, 2024

    Report

    Report Number
    3011581906-2024-00566
    Event Type
    Malfunction
    Date Received
    May 8, 2024
    Date of Event
    September 25, 2023
    Report Date
    April 8, 2024
    Manufacturer
    INFUTRONIX, LLC
    Product Code
    FRN
    UDI-DI
    00817170020093
    PMA / PMN Number
    K153193
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    A REVIEW OF THE DEVICE TESTING RECORD HAS BEEN COMPLETED. THE PUMP PASSED ALL PREVIOUS TESTS. COMPLAINT DATA WAS REVIEWED, THERE ARE NO PREVIOUS COMPLAINTS ON THIS DEVICE. EVALUATION OF THE RETURNED DEVICE WAS COMPLETED ON 5/3/2024: THE PUMP WAS RECEIVED WITH SOFTWARE VERSION NUMBER 5.6.2 AND LIBRARY CONFIGURATION "CH-NWA - V2". THE PUMP WAS TESTED WITH THE TESTING PROTOCOL FOR SYSTEM ERROR ALARM / MOTOR FUNCTIONS. THE PUMP'S EVENT LOG WAS PULLED AS PART OF THE EVALUATION AND UPON REVIEW IT WAS NOTED THAT THERE WAS EVIDENCE OF SEVERAL SYSTEM ERROR ALARMS IN THE PUMP'S EVENT LOG, 2 IN TOTAL, AS SEEN BY THE "E02" ALARM CODE. THE E02 ALARM CODES WERE FOLLOWED BY SUB CODE "44" WHICH MEANS "MOTOR OPEN" AND "MOTOR DELAY ISSUE", AND POINTS TO THE ROOT CAUSE OF THE SYSTEM ERROR ALARM. A 100 ML INFUSION WAS RAN ON THE PUMP USING THE END USER'S CURRENT PARAMETERS OF 100 ML OVER 48 HOURS, WITH A RATE OF 2.1 ML PER HOUR. THE INFUSION WAS ABLE TO SUCCESSFULLY COMPLETE AND THE PUMP DID NOT ALARM SYSTEM ERROR AFTER THE INFUSION BEGAN. THE INFUSION WAS RAN USING AN HS-008 IV CASSETTE WITH LOT # 2304023 AND EXPIRATION DATE 03/17/2026. UPON FURTHER EVALUATION THERE WERE NO LOOSE CONNECTIONS OR COMPONENTS INSIDE OF THE DEVICE. FUNCTIONAL TESTING DID CONFIRM THE REPORTED CONDITION AND WAS NOT DUPLICATED DURING TESTING. REPORTED ISSUE FOUND, DEVICE DOES NOT MEET SPECIFICATION. A CAPA HAS BEEN OPENED IN ORDER TO FULLY INVESTIGATE AND ADDRESS THE ROOT CAUSE OF THE REPORTED EVENT. THIS MDR WILL BE REOPENED AND UPDATED IN THE EVENT THE DEVICE INVOLVED OR ADDITIONAL INFORMATION BECOMES AVAILABLE. [REFERENCE: COMPLAINT # (B)(4).

    Description of Event or Problem · 0

    ON 01/31/2024, INFUTRONIX RECEIVED A REPORT THAT A PUMP STOPPED INFUSING DUE TO A SYSTEM ERROR ALERT. THE INFUSION CANNOT RESUME WITHOUT CAUSING DELAY IN TREATMENT. NO PATIENT INJURY. DEVICE WAS RETURNED ON 02/20/2024. DETAIL OF THE EVALUATION WAS IN SECTION H OF THIS MDR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    98683 NIMBUS II FLEX AMBULATORY INFUSION PUMP AMBULATORY INFUSION PUMP FRN INFUTRONIX, LLC NIMBUS II FLEX 170621-081 00817170020093

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown