BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NIMBUS II PLUS AMBULATORY INFUSION PUMP

    MDR report key: 16098731 · Received January 4, 2023

    Report

    Report Number
    3011581906-2022-00252
    Event Type
    Injury
    Date Received
    January 4, 2023
    Date of Event
    December 8, 2022
    Report Date
    October 12, 2023
    Manufacturer
    INFUTRONIX, LLC.
    Product Code
    FRN
    UDI-DI
    00817170020086
    PMA / PMN Number
    K153193
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE HAS BEEN RECEIVED. A FOLLOW UP MEDWATCH WILL BE SUBMITTED WHEN THE ANALYSIS IS COMPLETED.

    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 IS COMPLETE. THE RESULTS ARE BELOW: THE EVENT LOG WAS PULLED FOR REVIEW, THE ONLY CODE FOUND INSIDE OF THE LOG WERE 161 LINES OF E05_PRESSURE_DATA INDICATING THERE WERE MULTIPLE DOWNSTREAM OCCLUSION ALARMS DURING INFUSIONS. A 100 ML TEST INFUSION WAS SET UP AND THE DOWNSTREAM OCCLUSION ALARM WAS TESTED. THE LINE WAS CLAMPED, THE PUMP ALARMED DOWNSTREAM OCCLUSION UNTIL THE LINE WAS UNCLAMPED. THE DOWNSTREAM OCCLUSION ALARM CLEARED. THE PUMP RAN THE INFUSION TO COMPLETION WITHOUT ANOTHER OCCLUSION ALARM TAKING PLACE. THE PUMP FINISHED THE 100 ML INFUSION WITHOUT ANY FAILURES NOTED DURING THE INFUSION. THE PUMP WAS EVALUATED TO MEET ALL ACCEPTANCE CRITERIA PER OUR COMPLAINT INVESTIGATION WORK INSTRUCTION. PUMP PASSED EVERY TEST, AND NO FAILURES WERE FOUND DURING TESTING.

    Description of Event or Problem · 0

    A DISTRIBUTOR OF INFUTRONIX RECEIVED A COMPLAINT FROM A HEALTHCARE PROFESSIONAL (HCP), WHO REPORTED THAT AFTER THE PUMP WAS PLACED, AND INTERMITTENT BOLUS INFUSION WAS STARTED, THE PATIENT "CODED". PATIENT WAS RESUSCITATED, ADMITTED TO THE ICU, TREATED, AND HAS RECOVERED. HCP STATES THEY DO NOT BELIEVE THE PATIENT EXPERIENCED LAST (LOCAL ANESTHETIC TOXICITY). DEVICE OPERATOR WAS A NURSE. MEDICATION BEING INFUSED WAS UNKNOWN. THE CONTRACT MANUFACTURER OF THE AFFECTED DEVICE IS ZYNO ELECTRIC & MACHINERY LTD, SHANGHAI.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    908403 NIMBUS II PLUS AMBULATORY INFUSION PUMP AMBULATORY INFUSION PUMP FRN INFUTRONIX, LLC. NIMBUS II PLUS 1906271440 00817170020086

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention| L| H