BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NIMBUS II AMBULATORY INFUSION PUMP

    MDR report key: 12824067 · Received November 16, 2021

    Report

    Report Number
    3011581906-2021-00083
    Event Type
    Malfunction
    Date Received
    November 16, 2021
    Report Date
    December 6, 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 Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    A SERVICE PROVIDER OF INFUTRONIX PROVIDED THE EVALUATION REPORT FOR THE AFFECTED PUMP ON 11/17/2021. FLOW RATE TESTING CONFIRMED THAT THE FLOW RATE DEVIATION WAS -9.92%. THE FLOW RATE ACCURACY WAS NOT WITHIN +/- 5% SPECIFICATION. THE REPORTED FLOW RATE ISSUE WAS CONFIRMED. ROOT CAUSE CANNOT BE DETERMINED. PLEASE NOTE: FOR THE INVESTIGATION FINDINGS CODE, INFUTRONIX LLC DECIDED TO SELECT 4247 APPROPRIATE TERM/CODE NOT AVAILABLE, SUGGESTS ADDING THE PREFERRED TERM "ROOT CAUSE IS NOT IDENTIFIED." TO THE FUTURE CODE TABLE.

    Additional Manufacturer Narrative · 0

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

    Description of Event or Problem · 0

    THIS IS A FOLLOW-UP FOR THE INITIALLY FILED MDR 3011581906-2021-00083.

    Description of Event or Problem · 0

    ON (B)(6) 2021, INFUTRONIX RECEIVED A COMPLAINT FROM AN END USER: "PUMP DID NOT ADMINISTER THE RIGHT AMOUNT OF MEDICINE." DEVICE OPERATOR WAS A PATIENT. MEDICATION INFUSED WAS UNKNOWN. PATIENT WAS INVOLVED BUT NOT HARMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1716392 NIMBUS II AMBULATORY INFUSION PUMP AMBULATORY INFUSION PUMP FRN INFUTRONIX, LLC. NIMBUS II PLUS 200604960 00817170020161

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown