BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NIMBUS H AMBULATORY INFUSION PUMP

    MDR report key: 19095260 · Received April 12, 2024

    Report

    Report Number
    3011581906-2024-00530
    Event Type
    Malfunction
    Date Received
    April 12, 2024
    Date of Event
    October 15, 2021
    Report Date
    April 12, 2024
    Manufacturer
    INFUTRONIX, LLC
    Product Code
    FRN
    UDI-DI
    00817170020086
    PMA / PMN Number
    K153193
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INFUTRONIX ISSUED A PRODUCT QUALITY HOLD ORDER TO VERIFY ALL THE PRODUCTS IN THE INVENTORY ARE FREE FROM SIMILAR ISSUES THREE CUSTOMER LETTERS WERE SENT TO AFFECTED CUSTOMERS (B)(6) HOSPITAL. UNRELEASED VERSION 4 DUKE PROTOCOL LIBRARY INSTALLED ON THE NIMBUS PAINPRO (H) PUMP BY THE CUSTOMERS' SERVICE PROVIDER INSTEAD OF THE INTENDED DUKE V3 PROTOCOL LIBRARY INFUTRONIX ISSUED A HEALTH HAZARD EVALUATION INFUTRONIX ISSUED A FIELD ACTION PLAN TO ADDRESS THIS ISSUE. THIS FIELD ACTION WILL REPLACE THE AFFECTED INFUSION PUMP WITH PUMPS INSTALLED WITH THE CORRECT DUKE V3 PROTOCOL LIBRARY. DHR WAS REVIEWED, AND THE PUMP PASSED ALL PREVIOUS TESTS. RETURNED COMPLAINT DEVICES ARE NOT AVAILABLE AS OF 4/12/2024 OR RECERTIFIED POST-INVESTIGATION. INTENDED LIBRARY: DUKE V3. ACTUAL LIBRARY: DUKE V4 (UNRELEASED) BOTH VERSIONS OF THE DUKE LIBRARY SHARE THE SAME CLINICIAN CODE "191". THE DEVICE WAS OPERABLE BY THE USER.

    Description of Event or Problem · 0

    ON 10/19/2021 A COMPLAINT WAS OPENED IN QOS INTUVIE RECEIVED A COMPLAINT THAT THE PUMP HAS INCORRECT LIBRARY CONFIGURATION. UNRELEASED VERSION 4 DUKE PROTOCOL LIBRARY INSTALLED ON THE NIMBUS PAINPRO (H) PUMP BY THE CUSTOMERS' SERVICE PROVIDER INSTEAD OF THE INTENDED DUKE V3 PROTOCOL LIBRARY. NO OTHER DETAILS WERE PROVIDED ASSOCIATED WITH THE EVENT. NO PATIENT HARM WAS REPORTED IN THIS COMPLAINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1413001 NIMBUS H AMBULATORY INFUSION PUMP AMBULATORY INFUSION PUMP FRN INFUTRONIX, LLC NIMBUS H 2009231440 00817170020086

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown