BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NIMBUS II PLUS AMBULATORY INFUSION PUMP

    MDR report key: 18966360 · Received March 23, 2024

    Report

    Report Number
    3011581906-2024-00256
    Event Type
    Malfunction
    Date Received
    March 23, 2024
    Date of Event
    March 12, 2024
    Report Date
    April 5, 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
    003

    Narratives

    Additional Manufacturer Narrative · 0

    DHR PERFORMED AND REVIEWED. THERE IS A PREVIOUS COMPLAINT ON THIS PUMP FOR POWER ISSUES. THE PUMP PASSED ALL PREVIOUS TESTS. THE PUMP WAS RECEIVED ON 3/19/2024 AND ANALYSIS OF THE RETURNED DEVICE WAS COMPLETED ON 3/25/2024 THE PUMP'S EVENT LOG WAS ATTEMPTED TO BE PULLED, BUT THE DEVICE WAS UNABLE TO POWER ON AT ALL AND DID NOT ALLOW FOR THE LOG TO BE PULLED. THE PUMP WAS UNABLE TO POWER ON AT ALL, THEREFORE IT WAS UNABLE TO COMPLETE ANY INFUSION. SEVERAL BATTERIES WERE TRIED IN THE PUMP BUT IT WAS UNABLE TO POWER ON. THE DEVICE WAS OPENED AND THERE DID NOT APPEAR TO BE ANY VISIBLE DAMAGE OR LOOSE CONNECTIONS. FUNCTIONAL TESTING WAS UNABLE TO DUPLICATE THE REPORTED CONDITION, REVEALING THE DEVICE COULD NOT POWER ON, PREVENTING THE FLOW RATE ACCURACY FROM BEING TESTED. REPORTED ISSUE NOT FOUND, DEVICE NOT PERFORMING TO SPECIFICATION. A CAPA HAS BEEN OPENED IN ORDER TO FULLY DIAGNOSE AND ADDRESS THE ROOT CAUSE OF THE REPORTED EVENT.

    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 WAS ONE PREVIOUS COMPLAINT 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 3/192024, DEVICE IS RETURNED TO INTUVIE. THE ORIGINAL ISSUE IS NOT REPLICATED AND THE NEW ISSUES WERE OBSERVED WHERE THE DEVICE COULD NOT TURN ON EVENTHOUGH WE TRIED CHANGING SEVERAL BATTERIES. IT WAS NOTED THAT THE PUMP WAS ALSO BROKEN AT THE PLASTIC HOOKS AROUND THE METAL BARS ON THE BOTTOM OF THE PUMP'S HOUSING.

    Description of Event or Problem · 0

    ON 03/12/2024, INFUTRONIX RECEIVED A REPORT THAT A PUMP HAD A "FLOW RATE ISSUE NOT ADMINISTERING CORRECT DOSE". THE INFUSION CANNOT RESUME WITHOUT CAUSING DELAY IN TREATMENT. NO PATIENT HARMED. REQUESTED DEVICE TO BE RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    409640 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