BEUDAMED
    FDA Adverse Event Malfunction Summary report: Y

    NIMBUS II PLUS AMBULATORY INFUSION PUMP

    MDR report key: 18491440 · Received January 11, 2024

    Report

    Report Number
    3011581906-2024-00021
    Event Type
    Malfunction
    Date Received
    January 11, 2024
    Date of Event
    December 12, 2023
    Report Date
    February 21, 2024
    Manufacturer
    INFUTRONIX, LLC
    Product Code
    FRN
    UDI-DI
    00817170020161
    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 OTHER COMPLAINTS ON THIS DEVICE. THE PUMP WAS RECEIVED ON 1/24/2024 AND THE COMPLAINT WAS REOPENED ON 2/21/2024. DUE TO THE PUMP'S INITIAL COMPLAINT CODE OF 2POW3: POWER ISSUE - DEVICE POWERS SELF OFF, THE PUMP'S EVENT LOG WAS PULLED IN ORDER TO HIGHLIGHT ANY POTENTIAL ABRUPT POWER OFFS IN THE PUMP'S HISTORY. THE PUMP'S EVENT LOG WAS PULLED AND REVIEWED, HIGHLIGHTING LINES OF CODE WITH THE PHRASE "LOG_EVENT_ON" WITHOUT A LINE STATING "LOG_EVENT_OFF" BEFORE IT, MEANING THAT THE PUMP POWERED OFF ON IT'S OWN AND NEEDED TO BE TURNED BACK ON, AS SEEN BELOW: "EVENT 625: DATA: 5120 0 0 20 EVENTBYTES: 14 00 00 00 00 00 00 14 EVENT 626: DATA: 5120 171 256 192 EVENTBYTES: 14 00 00 AB 01 00 00 C0 EVENT 627: LOG_EVENT_DATA TIME: 165:52:28 TYPE: CURRENT_INFUSION_DATA DATA_LOG_END EVENTBYTES: 0B 52 28 02 40 01 00 C8 EVENT 628: LOG_EVENT_RUN TIME: 165:52:28 RATE: 30ML/HR REASON: LOG_RUN_CAUSE_PROG_RUN EVENTBYTES: 03 52 28 00 1E 00 01 9C EVENT 629: LOG_EVENT_ON TIME: 165:165:165 SOFTWARE_VERSION: 213 REASON: LOG_ON_CAUSE_ONOFF EVENTBYTES: 00 FF FF 00 D5 FF 2B FD EVENT 630: LOG_EVENT_MESSAGE TIME: 165:18:25 INVALID BOLUS KEY PRESSED: 3855 INVALID OTHER KEY PRESSED: 3855 EVENTBYTES: 09 18 25 FF FF 00 80 C4 EVENT 631: LOG_EVENT_OFF TIME: 165:18:25 RMP: 54061 REASON: LOG_OFF_CAUSE_SHUT EVENTBYTES: 01 18 25 00 D3 2D 2E 6C" THESE ABRUPT POWER OFFS CAN CAUSE THE PUMP'S INFUSION PARAMETERS TO BE COMPLETELY WIPED, NOT REMEMBERING THE STATE OF THE PRIOR INFUSION. THE PUMP'S EVENT LOG THAT WAS PULLED WILL BE ATTACHED TO THE COMPLAINT, SEE "(B)(6)". 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. THIS MDR WILL BE REOPENED AND UPDATED IN THE EVENT THE DEVICE INVOLVED OR ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 0

    ON 12/12/2023 A PUMP HAD AN ABRUPT POWER OFF WITHOUT WARNING. THE INFUSION PARAMATERS WERE LOST, AND THE INFUSION COULD NOT CONTINUE. THIS LED TO A DELAY IN THERAPY. PATIENT INVOLVED. NO PATIENT HARM WAS REPORTED. REQUESTED DEVICE RETURN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    731893 NIMBUS II PLUS AMBULATORY INFUSION PUMP AMBULATORY INFUSION PUMP FRN INFUTRONIX, LLC NIMBUS II PLUS 2208092040 00817170020161

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Female