BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NIMBUS II PAINPRO AMBULATORY INFUSION PUMP

    MDR report key: 19093243 · Received April 11, 2024

    Report

    Report Number
    3011581906-2024-00413
    Event Type
    Malfunction
    Date Received
    April 11, 2024
    Date of Event
    May 19, 2022
    Report Date
    April 18, 2024
    Manufacturer
    INFUTRONIX, LLC
    Product Code
    FRN
    UDI-DI
    00817170020086
    PMA / PMN Number
    K153193
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    A REVIEW OF THE DEVICE HISTORY RECORD HAS BEEN COMPLETED. THE PUMP PASSED ALL PREVIOUS TESTS. COMPLAINT DATA WAS REVIEWED, THERE ARE NO PREVIOUS COMPLAINTS ON THIS DEVICE. ANALYSIS OF THE RETURNED DEVICE WAS COMPLETED ON 4/11/2024: 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 INCORRECT LIBRARY. THERE IS RECORD ON IQOS OF THE PUMP BEING SENT THE INCORRECT LIBRARY CONFIGURATION, AND NO RECORD OF THE CORRECT LIBRARY BEING DOWNLOADED. THE PUMP'S OUTER BOX WAS LABELED WITH A STICKER WITH THE CORRECT ITEM CODE AND LIBRARY, BUT THE INCORRECT LIBRARY WAS CONFIGURED TO THE PUMP. FUNCTIONAL TESTING CONFIRMED THE REPORTED CONDITION AND WAS DUPLICATED DURING TESTING. REPORTED ISSUE FOUND, DEVICE NOT PERFORMING TO SPECIFICATION. A CAPA HAS BEEN OPENED IN ORDER TO FULLY INVESTIGATE AND ADDRESS THE ROOT CAUSE OF THE REPORTED EVENT. [REFERENCE COMPLAINT # (B)(4).

    Additional Manufacturer Narrative · 0

    THIS IS A FOLLOW-UP CORRECTION TO UPDATE THE FOLLOWING SECTIONS: DEVICE MANUFACTURER DATE THE ORIGINAL SUBMITTED INITIAL MDR STATED MANUFACTURE DATE WAS 9/23/2020, WHICH HAS NOW BEEN CORRECTED TO 6/9/2017.

    Additional Manufacturer Narrative · 0

    DHR WAS REVIEWED, AND THE PUMP PASSED ALL PREVIOUS TESTS. THERE ARE OTHER COMPLAINTS ON THIS DEVICE, SEE IT 2024N-0417, IT2024N-0572, AND (B)(4) IN CQ WHICH THIS IS AN EXTENSION OF. ANALYSIS OF THE RETURNED DEVICE WAS COMPLETED. THE PUMP WAS TESTED WITH THE TESTING PROTOCOL FOR SYSTEM ERROR ALARM / MOTOR FUNCTION. THE PUMP'S EVENT LOG WAS PULLED AS PART OF THE INVESTIGATION AND UPON REVIEW IT WAS NOTED THERE WAS NO EVIDENCE OF A SYSTEM ERROR AT ALL DURING THE PUMP'S INFUSION HISTORY THERE WERE ALSO SEVERAL UPSTREAM OCCLUSION ALARMS IN THE INFUSION HISTORY, 49 IN TOTAL, AS SEEN BY THE ALARM CODE "E04". A 100 ML INFUSION WAS RAN ON THE PUMP, USING THE CURRENT PARAMETERS OF 2.2 ML PER HOUR. THE INFUSION WAS UNABLE TO COMPLETE SUCCESSFULLY AS THE PUMP ABRUPTLY POWERED OFF BEFORE FINISHING. A NEW BATTERY WAS PUT INTO THE PUMP AND THE BATTERY LEVEL WAS RESET. THE PUMP ENDED UP POWERING OFF AFTER THE PUMP RAN AGAIN, BUT THERE WERE NO "SYSTEM ERROR" ALARMS NOTED AT ALL. FUNCTIONAL TESTING DID NOT CONFIRM THE REPORTED CONDITION AND WAS NOT DUPLICATED DURING TESTING. REPORTED ISSUE NOT FOUND, DEVICE NOT PERFORMING TO SPECIFICATION. THIS COMPLAINT IS PART OF CAPA.

    Description of Event or Problem · 0

    ON 05/19/2022, INFUTRONIX RECEIVED A REPORT FROM A HEALTHCARE FACILITY THAT THE PUMP WAS CONFIGURED INCORRECTLY. THE REPORTER INDICATED THAT THE PUMP HAD AN INCORRECT LIBRARY CONFIGURATION. NO PATIENT WAS INVOLVED IN THE REPORTED EVENT. DEVICE WAS RETURNED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    582122 NIMBUS II PAINPRO AMBULATORY INFUSION PUMP AMBULATORY INFUSION PUMP FRN INFUTRONIX, LLC NIMBUS II PAINPRO 171229-744 00817170020086

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown