BEUDAMED
    FDA Adverse Event Death Summary report: N

    NIMBUS II PLUS ABULATORY INFUSION PUMP

    MDR report key: 18022102 · Received October 27, 2023

    Report

    Report Number
    3011581906-2023-00194
    Event Type
    Death
    Date Received
    October 27, 2023
    Date of Event
    October 24, 2023
    Report Date
    October 27, 2023
    Manufacturer
    INFUTRONIX, LLC
    Product Code
    FRN
    UDI-DI
    00817170020161
    PMA / PMN Number
    K153193
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    A REVIEW OF THE DEVICE HISTORY RECORD HAS BEEN COMPLETED. THIS PUMP PASSED ALL PREVIOUS TESTS. COMPLAINT DATA WAS REVIEWED, THERE ARE NO PREVIOUS COMPLAINTS ON THIS DEVICE. ANALYSIS OF THE RETURNED DEVICE COULD NOT BE COMPLETED SINCE THE PUMP WAS LOST, AND NOT RETURNED FOR AN EVALUATION.

    Description of Event or Problem · 0

    AN EMPLOYEE OF INTUVIE RECEIVED A REPORT FROM A HEALTHCARE PROFESSIONAL THAT A PATIENT WENT TO THE HOSPITAL EMERGENCY ROOM AND EXPIRED WHILE CONNECTED TO THE PUMP. THE HEALTHCARE FACILITY DID NOT RECEIVE THE PUMP BACK FROM THE HOSPITAL EMERGENCY ROOM. PATIENT DEATH REPORTED. THE HEALTHCARE PROFESSIONAL STATED THE DEATH WAS DUE TO A CARDIAC ARREST, WHICH WAS NOT RELATED TO THE USE OF THE PUMP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1048884 NIMBUS II PLUS ABULATORY INFUSION PUMP AMBULATORY INFUSION PUMP FRN INFUTRONIX, LLC NIMBUS II PLUS 210325960 00817170020161

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Death