BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NIMBUS II AMBULATORY INFUSION PUMP

    MDR report key: 19094269 · Received April 12, 2024

    Report

    Report Number
    3011581906-2024-00293
    Event Type
    Malfunction
    Date Received
    April 12, 2024
    Date of Event
    April 15, 2019
    Report Date
    April 11, 2024
    Manufacturer
    INFUTRONIX, LLC
    Product Code
    FRN
    PMA / PMN Number
    K153193
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A REVIEW OF DEVICE HISTORY RECORD AND REVIEW OF PRODUCTION RECORDS CANNOT BE PERFORMED AS THERE IS NO SERIAL NUMBER OF THE PUMP MENTIONED WITHIN THE COMPLAINT RECEIVED. ALSO COMPLAINT DATA CANNOT BE REVIEWED ON THIS DEVICE. THIS IS A COMPLAINT FROM THE YEAR 2020. THE FOLLOW UP MDR WILL BE CREATED WHEN WE HAVE ADDITIONAL INFORMATION AVAILABLE ON THE PUMP. INVESTIGATION CANNOT BE PERFORMED AS PUMP IS NOT AVAILABLE FOR EVALUATION. A CAPA HAS BEEN OPENED IN ORDER TO FULLY DIAGNOSE AND ADDRESS THE ROOT CAUSE OF THE REPORTED EVENT. INTENDED LIBRARY: (B)(6). ACTUAL LIBRARY: (B)(6). SPECIFIC LIBRARY VERSION UNKNOWN, BUT THESE ACCOUNTS USE DIFFERENT CLINICIAN CODES. DEVICE RENDERED INOPERABLE FOR THE USER WHICH RECEIVED IT.

    Description of Event or Problem · 0

    ON 12/10/2020 A COMPLAINT WAS OPENED IN QOS INTUVIE RECEIVED A COMPLAINT THAT THE PUMP HAS INCORRECT LIBRARY CONFIGURATION. 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
    1412930 NIMBUS II AMBULATORY INFUSION PUMP AMBULATORY INFUSION PUMP FRN INFUTRONIX, LLC N/I N/I

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown