BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NIMBUS II PLUS AMBULATORY INFUSION PUMP

    MDR report key: 18627490 · Received February 1, 2024

    Report

    Report Number
    3011581906-2024-00106
    Event Type
    Malfunction
    Date Received
    February 1, 2024
    Date of Event
    January 18, 2024
    Report Date
    June 8, 2024
    Manufacturer
    INFUTRONIX, LLC
    Product Code
    FRN
    UDI-DI
    00817170020161
    PMA / PMN Number
    K153193
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    501

    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. THIS MDR WILL BE REOPENED AND UPDATED IN THE EVENT THE DEVICE INVOLVED OR ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Additional Manufacturer Narrative · 0

    THIS COMPLAINT RECORD IS BEING REOPENED FOR DEVICE EVALUATION DUE TO THE DEVICE BEING RETURNED. THERE ARE NO PREVIOUS COMPLAINTS ON THIS DEVICE. THE PUMP'S RECORDS IN QOS IN SALESFORCE WERE REVIEWED, AS ALL PREVIOUS TEST RECORDS WERE REVIEWED AND ALL WERE FOUND TO HAVE PASSED, WITH MANUFACTURING FINAL TESTING BEING COMPLETED ON (B)(6) 2023. THE PUMP WAS RECEIVED FOR EVALUATION ON (B)(6) 2024 WITH SOFTWARE VERSION NUMBER 5.9.2 AND LIBRARY CONFIGURATION "OPTMOB - V2", WHICH WAS THE LIBRARY CONFIGURED TO THE PUMP. THE PUMP WAS TESTED WITH THE FOLLOWING TESTING PROTOCOL FOR BATTERY AND POWER COMPLAINTS. THE PUMP'S EVENT LOG WAS PULLED AS PART OF THE EVALUATION AND UPON REVIEW IT WAS NOTED THAT THERE WAS NO EVIDENCE OF AN ABRUPT POWER OFF FOUND IN THE LOG, AS REPORTED BY THE END USER. SEEING THE CODE "LOG_EVENT_ON" CODE WITHOUT AN "LOG_EVENT_OFF" CODE BEFORE IT WOULD HAVE REVEALED AN 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. NO EVIDENCE OF THIS WAS FOUND IN THE LOG. A 100 ML INFUSION WAS UNABLE TO BE RAN ON A PUMP DUE TO A LIMITATION WITH THE CUSTOMER'S LIBRARY CONFIGURATION. THE PUMP WAS SET TO RUN A 20 ML INFUSION AT A RATE OF 0.5 ML PER HOUR, USING THE PUMP'S CURRENT PARAMETERS. 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. UPON FURTHER EVALUATION THERE WERE NO LOOSE CONNECTIONS OR COMPONENTS INSIDE OF THE DEVICE, WHICH COULD HAVE CONTRIBUTED TO THE REPORTED MALFUNCTION. FUNCTIONAL TESTING DID NOT CONFIRM THE REPORTED CONDITION AND WAS UNABLE TO BE DUPLICATED. IT WAS ALSO NOTED THAT THE PUMP'S LABEL WITH ALL OF THE MODEL INFORMATION WAS ALMOST COMPLETELY ERASED, AND THE QR CODE LABEL IS SLIGHTLY DAMAGED AND BEGINNING TO FALL OFF. THE ONLY WAY TO FULLY VERIFY THE PUMP'S INFORMATION IS BY PHYSICALLY TURNING IT ON TO SEE ALL INFORMATION AS IT POWERS UP. THE PUMP'S HOUSING WAS ALSO SLIGHTLY BROKEN WHERE THE BATTERY COVER CLIPS INTO THE PUMP. REPORTED ISSUE NOT FOUND, DEVICE DOES NOT MEET SPECIFICATION. THERE WAS NO CLINICAL OR IMPACT HEALTH EFFECTS ASSOCIATED WITH THIS REPORT. THIS COMPLAINT HAS BEEN REVIEWED, EVALUATED, AND DETERMINED TO BE A PART OF CAPA. REFERENCE COMPLAINT # (B)(4).

    Description of Event or Problem · 0

    ON (B)(6) 2024, INFUTRONIX RECEIVED A REPORT THAT A PUMP POWERED OFF ON ITS OWN WITHOUT WARNING, 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
    1348373 NIMBUS II PLUS AMBULATORY INFUSION PUMP AMBULATORY INFUSION PUMP FRN INFUTRONIX, LLC NIMBUS II PLUS 2208092640 00817170020161

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown