BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NIMBUS II PLUS AMBULATORY INFUSION PUMP

    MDR report key: 19112480 · Received April 15, 2024

    Report

    Report Number
    3011581906-2024-00150
    Event Type
    Malfunction
    Date Received
    April 15, 2024
    Date of Event
    February 16, 2024
    Report Date
    May 15, 2024
    Manufacturer
    INFUTRONIX, LLC
    Product Code
    FRN
    UDI-DI
    00817170020161
    PMA / PMN Number
    K153193
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THERE WAS ONLY ONE CHANGE IN THIS MDR FOLLOWUP2. IN SECTION G3, DATE RECEIVED BY MANUFACTURER SHOULD BE 08MARCH2024, RATHER THAN BLANK AS IN FOLLOWUP1. REFERENCE TO COMPLAINT # (B)(4)-FOLLOWUP2.

    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. ANALYSIS OF THE RETURNED DEVICE WAS ON 3/21/2024. THE RESULTS ARE BELOW: THE EVENT LOG WAS REVIEWED, AND SHOWS THAT THERE WAS AN ABRUPT POWER OFF DURING AN INFUSION WITHOUT ANY ALERT OR ALARM ON THE PUMP 71ML'S INTO A 138 ML INFUSION. REFER TO THE EVENT LOG ATTACHMENT ON THIS FILE FOR THE COMPLETE LOG. HOWEVER, DURING FUNCTIONAL TESTING, THE REPORTED PROBLEM WAS NOT DUPLICATED. THE PUMP FINISHED A 138 ML INFUSION WITHOUT AN ABRUPT POWER OFF TAKING PLACE. THE REPORTED ISSUE OF ABRUPT POWER OFF WAS CONFIRMED. A CAPA HAS BEEN OPENED IN ORDER TO FULLY INVESTIGATE AND ADDRESS THE ROOT CAUSE OF THE REPORTED EVENT.

    Additional Manufacturer Narrative · 0

    THERE WAS ONLY ONE CHANGE IN THIS MDR. IN SECTION B5, DESCRIBE EVENT OR PROBLEM. IT WAS CHANGED TO "ON 02/20/2024, INFUTRONIX RECEIVED A REPORT THAT A PUMP WAS "RESET AND RESTARTED' ON ITS OWN. THE THERAPY WAS DISCONTINUED AND DEVICE WAS RETURNED ON 03/08/2024. DETAIL OF THE EVALUATION CAN BE FOUND IN SECTION H OF THIS MDR."

    Description of Event or Problem · 0

    ON 02/2/2024, 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. NO PATIENT WAS INVOLVED AND HARMED. DEVICE WAS RETURNED ON 03/08/2024. DETAIL OF THE EVALUATION CAN BE FOUND IN SECTION H OF THIS MDR.

    Description of Event or Problem · 0

    ON 02/20/2024, INFUTRONIX RECEIVED A REPORT THAT A PUMP WAS "RESET AND RESTARTED' ON ITS OWN. THE THERAPY WAS DISCONTINUED AND DEVICE WAS RETURNED ON 03/08/2024. DETAIL OF THE EVALUATION CAN BE FOUND IN SECTION H OF THIS MDR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1445654 NIMBUS II PLUS AMBULATORY INFUSION PUMP AMBULATORY INFUSION PUMP FRN INFUTRONIX, LLC NIMBUS II PLUS 2208092040 00817170020161

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown