BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NIMBUS II AMBULATORY INFUSION PUMP

    MDR report key: 19094302 · Received April 12, 2024

    Report

    Report Number
    3011581906-2024-00297
    Event Type
    Malfunction
    Date Received
    April 12, 2024
    Date of Event
    June 22, 2020
    Report Date
    April 12, 2024
    Manufacturer
    INFUTRONIX, LLC
    Product Code
    FRN
    PMA / PMN Number
    K153193
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    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: DUKE V3. ACTUAL LIBRARY: DEFAULT (H PUMP). DUKE V3 LIBRARY UTILIZES CLINICIAN CODE "191", WHICH IS DIFFERENT THAN THE DEAFULT (H PUMP) CLINICIAN CODE "019". THE DEVICE WAS NOT OPERABLE BY THE USER.

    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
    769761 NIMBUS II AMBULATORY INFUSION PUMP AMBULATORY INFUSION PUMP FRN INFUTRONIX, LLC N/I N/I

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown