BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NIMBUS II PLUS AMBULATORY INFUSION PUMP

    MDR report key: 19157430 · Received April 22, 2024

    Report

    Report Number
    3011581906-2024-00541
    Event Type
    Malfunction
    Date Received
    April 22, 2024
    Date of Event
    April 8, 2024
    Report Date
    May 5, 2025
    Manufacturer
    INFUTRONIX, LLC
    Product Code
    FRN
    UDI-DI
    00817170020161
    PMA / PMN Number
    K153193
    Removal / Correction Number
    Z- 1285-2024
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    003

    Narratives

    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. 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.

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENT IS PART OF OUR RETROSPECTIVE 2024 COMPLAINT REMEDIATION. THE PUMP WAS RETURNED AND TESTED: THE PUMP'S EVENT LOG WAS PULLED AS PART OF THE EVALUATION AND UPON REVIEW IT WAS NOTED THAT THERE WERE SEVERAL ABRUPT POWER OFFS FOUND IN THE LOG, AS REPORTED BY THE END USER. AN ABRUPT POWER OFF CAN BE SEEN BELOW ON EVENT LINE 102 BY THE "LOG_EVENT_ON" CODE WITHOUT AN "LOG_EVENT_OFF" CODE BEFORE IT: "EVENT 97: DATA: 5272 0 0 172 EVENTBYTES: 14 98 00 00 00 00 00 AC EVENT 98: DATA: 5120 0 0 20 EVENTBYTES: 14 00 00 00 00 00 00 14 EVENT 99: DATA: 5120 171 256 192 EVENTBYTES: 14 00 00 AB 01 00 00 C0 EVENT 100: LOG_EVENT_DATA TIME: 18:13:41 TYPE: CURRENT_INFUSION_DATA DATA_LOG_END EVENTBYTES: 0B 13 41 02 40 01 00 A2 EVENT 101: LOG_EVENT_RUN TIME: 18:13:41 RATE: 4ML/HR REASON: LOG_RUN_CAUSE_PROG_RUN EVENTBYTES: 03 13 41 00 04 00 01 5C EVENT 102: LOG_EVENT_ON TIME: 165:165:165 SOFTWARE_VERSION: 213 REASON: LOG_ON_CAUSE_ONOFF EVENTBYTES: 00 FF 00 D5 FF 2B FD EVENT 103: LOG_EVENT_SET_RV TIME: 165:32:18 VTBI: 87ML RATE: 4ML/HR EVENTBYTES: 07 32 18 00 57 00 04 AC EVENT 104: LOG_EVENT_DATA TIME: 165:32:18 TYPE: CURRENT_INFUSION_DATA DATA_LOG_START EVENTBYTES: 0B 32 18 02 40 00 00 97 EVENT 105: DATA: 5198 22096 8257 27861 EVENTBYTES: 14 4E 56 50 20 41 6C D5 EVENT 106: DATA: 5228 0 1024 132 EVENTBYTES: 14 6C 00 00 04 00 00 84 ". SEEING THE CODE "LOG_EVENT_ON" CODE WITHOUT AN "LOG_EVENT_OFF" CODE BEFORE IT POINTS TO THE ABRUPT POWER OFF AS IT MEANS THAT THE PUMP HAD TO BE POWERED ON WITHOUT BEING POWERED OFF PRIOR, MEANING THAT IT TURNED OFF ON ITS OWN. THE PUMP'S EVENT LOG THAT WAS PULLED WILL BE ATTACHED, SEE "SN (B)(6)". A 20 ML INFUSION WAS RAN ON THE PUMP INSTEAD OF A 100 ML INFUSION DUE TO A LIMITATION ON THE END USER'S CUSTOM LIBRARY. THE INFUSION RAN FOR 20 ML AT A RATE OF 2.2 ML PER HOUR. THE INFUSION WAS SUCCESSFULLY COMPLETED AND THE PUMP DID NOT POWER OFF ABRUPTLY BEFORE FINISHING. THE INFUSION WAS RAN USING AN HS-008 IV CASSETTE WITH LOT # 2304023 AND EXPIRATION DATE 03/17/2026. IT WAS ALSO NOTED THAT THE LABEL ON THE BACK OF THE PUMP WITH THE PUMP MODEL INFORMATION IS COMPLETELY ERASED. AN IMAGE WILL BE ATTACHED, SEE "(B)(6) LABEL". UPON FURTHER EVALUATION THERE WERE NO LOOSE CONNECTIONS OR COMPONENTS INSIDE OF THE DEVICE. FUNCTIONAL TESTING DID CONFIRM THE REPORTED CONDITION BUT WAS NOT DUPLICATED DURING TESTING. THE CAUSE REMAINS UNDETERMINED. REPORTED ISSUE FOUND, DEVICE DOES NOT MEET SPECIFICATION. FURTHER INVESTIGATION OF THIS PUMP IS EXCLUDED AS THE FAILURE MODE FOR THIS DEVICE HAS BEEN PREVIOUSLY INVESTIGATED THROUGH PRODUCT CAPA IT2023-15 AND THIS PRODUCT HAS BEEN REMOVED FROM THE MARKET UNDER RECALL Z- 1285-2024. REFERENCE TO COMPLAINT# (B)(6).

    Description of Event or Problem · 0

    ON 04/15/2024, INFUTRONIX RECEIVED A REPORT THAT A PUMP HAD POWER ISSUE - DEVICE POWERS SELF OFF. THE INFUSION CANNOT RESUME WITHOUT CAUSING DELAY IN TREATMENT. NO PATIENT WAS HARMED. DEVICE WAS REQUESTED TO BE RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1408051 NIMBUS II PLUS AMBULATORY INFUSION PUMP AMBULATORY INFUSION PUMP FRN INFUTRONIX, LLC NIMBUS II PLUS 2206213120 00817170020161

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown