BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NIMBUS II FLEX AMBULATORY INFUSION PUMP

    MDR report key: 19391469 · Received May 24, 2024

    Report

    Report Number
    3011581906-2024-00585
    Event Type
    Malfunction
    Date Received
    May 24, 2024
    Date of Event
    April 24, 2024
    Report Date
    May 24, 2024
    Manufacturer
    INFUTRONIX, LLC
    Product Code
    FRN
    UDI-DI
    00817170020093
    PMA / PMN Number
    K153193
    Removal / Correction Number
    Z-1285-2024
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE HISTORICAL TEST RECORDS WERE REVIEWED IN THE QOS SYSTEM. ALL TEST RESULTS RELEVANT TO THE REPORTED ISSUE HAD PASSED. THERE WAS NO PREVIOUS COMPLAINT ON THIS DEVICE. THIS MDR WILL BE REOPENED AND UPDATED IN THE EVENT THE PRODUCT INVOLVED OR ADDITIONAL INFORMATION BECOMES AVAILABLE. A CAPA HAD BEEN OPENED IN ORDER TO FULLY INVESTIGATE AND ADDRESS THE ROOT CAUSES OF THE REPORTED EVENTS AFTER THE EVALUATION. REFERENCE TO COMPLAINT # (B)(4).

    Description of Event or Problem · 0

    ON 04/24/2024, INFUTRONIX RECEIVED A REPORT THAT A PUMP HAD A FLOW RATE ISSUE - USER REPORTS FLOW RATE ISSUE. BUT THE FLOW RATE ACCURACY WAS UNKNOWN. THE PUMP WAS ALLEGEDLY WAS HAVING TREATMENT BUT DID NOT INFUSE COMPLETELY. NO PATIENT WAS NOT HARMED. DEVICE WAS REQUESTED TO BE RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    664208 NIMBUS II FLEX AMBULATORY INFUSION PUMP AMBULATORY INFUSION PUMP FRN INFUTRONIX, LLC NIMBUS II FLEX 180517720 00817170020093

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown