BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NIMBUS II PAINPRO AMBULATORY INFUSION PUMP

    MDR report key: 19093081 · Received April 11, 2024

    Report

    Report Number
    3011581906-2024-00412
    Event Type
    Malfunction
    Date Received
    April 11, 2024
    Date of Event
    May 19, 2022
    Report Date
    April 11, 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

    THE ORIGINAL SUBMITTED INITIAL MDR STATED MANUFACTURE DATE WAS 9/23/2020, WHICH HAS NOW BEEN CORRECTED TO 10/23/2019.

    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. THE LABEL ON THE PUMP'S OUTER BOX ALSO WAS FOUND TO HAVE THE WRONG SERIAL NUMBER ON THE LABEL, IT WAS NOT THE PUMP THAT WAS ACTUALLY IN THE BOX OR ON THE PACKING SLIP ALONG WITH THE REST OF THE PUMPS IN THE CASE. THE COMPLAINT RECORD WAS UPDATED TO REFLECT THE CORRECT PUMP SERIAL NUMBER. 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)].

    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
    1407456 NIMBUS II PAINPRO AMBULATORY INFUSION PUMP AMBULATORY INFUSION PUMP FRN INFUTRONIX, LLC NIMBUS II PAINPRO 191023480 00817170020086

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown