BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NIMBUS II PLUS AMBULATORY INFUSION PUMP

    MDR report key: 19068559 · Received April 8, 2024

    Report

    Report Number
    3011581906-2024-00481
    Event Type
    Malfunction
    Date Received
    April 8, 2024
    Date of Event
    December 29, 2022
    Report Date
    April 9, 2024
    Manufacturer
    INFUTRONIX, LLC
    Product Code
    FRN
    UDI-DI
    00817170020086
    PMA / PMN Number
    K153193
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FILE WAS RE-OPENED AS PART OF A RETROSPECTIVE REVIEW OF COMPLAINTS FOR INCORRECT LIBRARY AND IT'S ASSOCIATED CAPA WHEREIN THIS FILE WAS IDENTIFIED AS NEEDING A MDR TO REPORT THE INSTANCE OF INCORRECT LIBRARY TO THE FDA. ANALYSIS OF THE RETURNED DEVICE WAS COMPLETED. THE PUMP WAS TESTED WITH THE TESTING PROTOCOL FOR INCORRECT SOFTWARE ISSUES. THE PUMP WAS POWERED ON AND THE PUMP WAS CONFIRMED TO HAVE THE LIBRARY "PLUS-V1". THE PUMP WAS SUPPOSED TO BE PROGRAMMED WITH THE LIBRARY "CHEMO V2", BUT THE LIBRARY WAS NEVER DOWNLOADED ONTO THE PUMP. THERE IS NO RECORD ON IQOS OF THE PUMP EVER BEING SENT THE CORRECT LIBRARY CONFIGURATION, AND NO RECORD OF THE CORRECT LIBRARY BEING DOWNLOADED. FUNCTIONAL TESTING CONFIRMED THE REPORTED CONDITION AND WAS DUPLICATED DURING TESTING. REPORTED ISSUE FOUND, DEVICE NOT PERFORMING TO SPECIFICATION. THIS COMPLAINT HAS BEEN REVIEWED, EVALUATED, AND DETERMINED TO BE A PART OF CAPA.

    Description of Event or Problem · 0

    ON 12/29/2022, (B)(6) OF INTUVIE RECEIVED AN EMAIL FROM (B)(6) OF 44100-(B)(6). CUSTOMER REPORTED THAT PUMP 714065 "INCORRECT DRUG LIBRARY". NO FURTHER DETAILS WERE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2288418 NIMBUS II PLUS AMBULATORY INFUSION PUMP AMBULATORY INFUSION PUMP FRN INFUTRONIX, LLC NIMBUS II PLUS 2206213120 00817170020086

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown