BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NIMBUS II FLEX AMBULATORY INFUSION PUMP

    MDR report key: 18474811 · Received January 9, 2024

    Report

    Report Number
    3011581906-2023-00790
    Event Type
    Malfunction
    Date Received
    January 9, 2024
    Date of Event
    December 26, 2023
    Report Date
    February 14, 2024
    Manufacturer
    INFUTRONIX, LLC
    Product Code
    FRN
    UDI-DI
    00817170020093
    PMA / PMN Number
    K153193
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    DHR WAS REVIEWED, AND THE PUMP PASSED ALL PREVIOUS TESTS. THERE ARE NO PREVIOUS COMPLAINTS ON THIS DEVICE. THE PUMP WAS RECEIVED ON 2/12/2024 AND TESTED ON 2/14/2024. DUE TO THE PUMP'S INITIAL COMPLAINT CODE OF "2POW3: POWER ISSUE - DEVICE POWERS SELF OFF", THE PUMP'S EVENT LOG WAS PULLED AND REVIEWED TO SEE IF THERE IS ANY EVIDENCE OF AN ABRUPT POWER OFF IN THE PUMP'S HISTORY. AN ABRUPT POWER OFF CAN BE SEEN BY THE CODE "LOG_EVENT_ON", WITHOUT THE LINE "LOG_EVENT_OFF" BEFORE IT. THIS MEANS THAT THE PUMP POWERED OFF ON ITS OWN AND NEEDED TO BE TURNED BACK ON. THE EVENT LOG CAN BE SEEN BELOW: "EVENT 608: LOG_EVENT_MESSAGE TIME: 03:57:98 INVALID BOLUS KEY PRESSED: 0 INVALID OTHER KEY PRESSED: 0 EVENT BYTES: 09 57 98 00 00 00 80 78 EVENT 609: LOG_EVENT_OFF TIME: 03:57:98 RMP: 213121 REASON: LOG_OFF_CAUSE_SHUT EVENT BYTES: 01 57 98 03 40 81 2E E2 EVENT 610: LOG_EVENT_ON TIME: 165:165:165 SOFTWARE_VERSION: 213 REASON: LOG_ON_CAUSE_ON/OFF EVENT BYTES: 00 FF FF 00 D5 FF 2B FD EVENT 611: LOG_EVENT_ON TIME: 165:165:165 SOFTWARE_VERSION: 213 REASON: LOG_ON_CAUSE_ON/OFF EVENT BYTES: 00 FF FF 00 D5 FF 2B FD EVENT 612: LOG_EVENT_SAVE_RX TIME: 165:00:47 EVENT BYTES: 06 00 47 00 D5 FF 2B 4C EVENT 613: LOG_EVENT_DATA TIME: 165:00:47 TYPE: CURRENT_PRESCRIPTION_DATA DATA_LOG_START EVENT BYTES: 0B 00 47 03 40 00 00 95 EVENT 614: DATA: 5202 12118 21570 18890 EVENT BYTES: 14 52 2F 56 54 42 49 CA EVENT 615: DATA: 5120 0 5632 42 EVENT BYTES: 14 00 00 00 16 00 00 2A EVENT 616: DATA: 5120 0 0 20 EVENT BYTES: 14 00 00 00 00 00 00 14." THE CONSECUTIVE LINES OF "LOG_EVENT_ON" CAN BE SEEN, PROVING THAT THE PUMP DID ABRUPTLY POWER OFF AS REPORTED. IT WAS ALSO NOTED THAT THE PUMP HAS SUSTAINED SERIOUS PHYSICAL DAMAGE, WITH THE PLASTIC HOUSING BEING COMPLETELY BROKEN AROUND THE METAL BAR ON THE BOTTOM OF THE PUMP, ALONG WITH THE LCD SCREEN HAVING BLACK SPOTS ON IT. THERE ALSO APPEARS TO BE FLUID DRIED INSIDE OF THE PUMP, WHICH COULD HAVE CAUSED THE POWER OFF. THE ANALYSIS OF THE RETURNED DEVICE IS COMPLETE. THIS COMPLAINT WAS REVIEWED, AND THE RETURN PRODUCT EVALUATED AND DETERMINED TO BE INCLUDED IN CAPA#: IT2023-15 FOR POWER/BATTERY, CAPA#: IT2023-18 FOR LCD MODULE AND CAPA#: IT2023-19 FOR PUMP HOUSING MODULE. REPORTED ISSUE FOUND, DEVICE NOT PERFORMING TO SPECIFICATION.

    Additional Manufacturer Narrative · 0

    A REVIEW OF THE DEVICE HISTORY RECORD HAS BEEN COMPLETED. THE PUMP PASSED ALL PREVIOUS TESTS. COMPLAINT DATA WAS REVIEWED, THERE ARE NO PREVIOUS COMPLAINTS ON THIS DEVICE. DEVICE RETURN REQUESTED.

    Description of Event or Problem · 0

    ON (B)(6) 2023, INFUTRONIX RECEIVED A REPORT THAT A PUMP HAD A SYSTEM ERROR, CAUSING LOSS OF INFUSION PARAMETERS. THE INFUSION CANNOT RESUME WITHOUT CAUSING DELAY IN TREATMENT. REQUESTED DEVICE TO BE RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    605846 NIMBUS II FLEX AMBULATORY INFUSION PUMP AMBULATORY INFUSION PUMP FRN INFUTRONIX, LLC NIMBUS II FLEX 210219600 00817170020093

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown