BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NIMBUS II PLUS AMBULATORY INFUSION PUMP

    MDR report key: 17699733 · Received September 7, 2023

    Report

    Report Number
    3011581906-2023-00165
    Event Type
    Malfunction
    Date Received
    September 7, 2023
    Date of Event
    August 11, 2023
    Report Date
    October 19, 2023
    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

    ANALYSIS OF THE RETURNED DEVICE IS COMPLETE. THE RESULTS ARE BELOW: A REVIEW OF THE DEVICE HISTORY RECORD HAS BEEN COMPLETED. THIS PUMP PASSED ALL PREVIOUS TESTS. COMPLAINT DATA WAS WAS REVIEWED, THERE ARE NO PREVIOUS COMPLAINTS ON THIS DEVICE. ANALYSIS OF THE RETURNED DEVICE IS COMPLETE. THE RESULTS ARE BELOW: THE PUMP WAS THEN CONNECTED TO AN ADMINISTRATION SET (HS-008, LOT # 2203016) AND THE DOWNSTREAM OCCLUSION ALARM WAS TESTED. A 20 ML INFUSION WAS STARTED, AND THE DISTAL END OF THE TUBING WAS CLAMPED, AND THE COMPLETE DOWNSTREAM OCCLUSION ALARM WAS TRIGGERED, INCLUDING THE AUDIO QUEUE. THE LINE WAS UNCLAMPED, AND THE INFUSION RAN UNTIL COMPLETION WITHOUT A FALSE DOWNSTREAM OCCLUSION ALARM TAKING PLACE. THE REPORTED ISSUE IS NOT CONFIRMED. PUMP MEETS PASSING CRITERIA.

    Additional Manufacturer Narrative · 0

    ANALYSIS OF THE RETURNED DEVICE IS COMPLETE. THE RESULTS ARE BELOW: A REVIEW OF THE DEVICE HISTORY RECORD HAS BEEN COMPLETED. THIS PUMP PASSED ALL PREVIOUS TESTS. COMPLAINT DATA WAS WAS REVIEWED, THERE ARE NO PREVIOUS COMPLAINTS ON THIS DEVICE. ANALYSIS OF THE RETURNED DEVICE IS COMPLETE. THE RESULTS ARE BELOW: THE PUMP WAS THEN CONNECTED TO AN ADMINISTRATION SET (HS-008, LOT # 2203016) AND THE DOWNSTREAM OCCLUSION ALARM WAS TESTED. A 20 ML INFUSION WAS STARTED, AND THE DISTAL END OF THE TUBING WAS CLAMPED, AND THE COMPLETE DOWNSTREAM OCCLUSION ALARM WAS TRIGGERED, INCLUDING THE AUDIO QUEUE. THE LINE WAS UNCLAMPED, AND THE INFUSION RAN UNTIL COMPLETION WITHOUT A FALSE DOWNSTREAM OCCLUSION ALARM TAKING PLACE. THE REPORTED ISSUE IS NOT CONFIRMED. PUMP MEETS PASSING CRITERIA.

    Additional Manufacturer Narrative · 0

    RETURN OF THE DEVICE HAS BEEN REQUESTED. AS OF THE DATE OF THIS REPORT, DEVICE HAS NOT BEEN RETURNED.

    Description of Event or Problem · 0

    (B)(4)NO DOWNSTREAM ALARM.

    Description of Event or Problem · 0

    (B)(4)NO DOWNSTREAM ALARM.

    Description of Event or Problem · 0

    (B)(6): NO DOWNSTREAM ALARM. HEALTHCARE PROFESSIONAL REPORTED DEVICE DID NOT ALARM UPON DOWNSTREAM OCCLUSION. MEDICATION BEING INFUSED WAS IS UNKNOWN. NO PATIENT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1293011 NIMBUS II PLUS AMBULATORY INFUSION PUMP AMBULATORY INFUSION PUMP FRN INFUTRONIX, LLC NIMBUS II PLUS 200903960 00817170020161

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown