BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NIMBUS II PLUS

    MDR report key: 10939440 · Received December 3, 2020

    Report

    Report Number
    3011581906-2020-00073
    Event Type
    Malfunction
    Date Received
    December 3, 2020
    Date of Event
    October 27, 2020
    Report Date
    April 8, 2021
    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
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    A SERVICE PROVIDER OF INFUTRONIX PROVIDED THE EVALUATION REPORT FOR THE AFFECTED PUMP ON 04/08/2021. FLOW RATE TESTING CONFIRMED THAT THE FLOW RATE DEVIATION WAS -6.2%. THE FLOW RATE ACCURACY WAS NOT WITHIN THE +/-5% SPECIFICATION. THE REPORTED FLOW RATE ISSUE WAS CONFIRMED. PLEASE NOTE: FOR THE INVESTIGATION FINDINGS CODE, INFUTRONIX LLC DECIDED TO SELECT 4247 APPROPRIATE TERM/CODE NOT AVAILABLE, SUGGETS ADDING THE PREFERRED TERM "ROOT CAUSE IS NOT IDENTIFIED." TO THE FUTURE CODE TABLE.

    Description of Event or Problem · 0

    THIS IS A FOLLOW-UP FOR THE INITIALLY FILED MDR 3011581906-2020-00073.

    Additional Manufacturer Narrative · 1

    INFUTRONIX IS WAITING FOR THE DEVICE TO BE RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    ON 11/05/2020, A DISTRIBUTOR OF INFUTRONIX REPORTED AN ISSUE ON BEHALF OF AN END USER: "PUMP (B)(4) WAS NOT INFUSING THE CORRECT AMOUNT OF MEDICATION." A PATIENT WAS INVOLVED BUT WAS NOT HARMED OR INJURED. THE MEDICATION BEING INFUSED WAS UNKNOWN. DEVICE OPERATOR WAS A PATIENT. A PATIENT WAS INVOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1404848 NIMBUS II PLUS AMBULATORY INFUSION PUMP FRN INFUTRONIX, LLC NIMBUS II PLUS 200604960 00817170020161

    Patients

    Seq Age Sex Outcome Treatment
    1