BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NIMBUS II PLUS AMBULATORY INFUSION PUMP

    MDR report key: 18986132 · Received March 27, 2024

    Report

    Report Number
    3011581906-2024-00349
    Event Type
    Malfunction
    Date Received
    March 27, 2024
    Date of Event
    March 11, 2024
    Report Date
    June 13, 2024
    Manufacturer
    INFUTRONIX, LLC
    Product Code
    FRN
    UDI-DI
    00817170020161
    PMA / PMN Number
    K153193
    Removal / Correction Number
    Z-1285-2024
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE PUMP WAS MANUFACTURED ON 06/21/2022 AND IS INCLUDED IN LOT # 2206213120 WHICH WAS A BATCH OF (B)(4) PUMPS, WAS RECEIVED AND ACCEPTED INITIALLY FROM MANUFACTURING ON 10/20/2022 IN A GROUP OF 831 PUMPS, AND APPROVED ON 10/24/2022. THE PUMP WAS MOST RECENTLY SHIPPED TO THE CUSTOMER UNITED HEALTH CARE SERVICES INC / OPTUM, WHO REPORTED THE COMPLAINT, ON 12/08/2022 AND WAS CONFIGURED TO THE CUSTOMER'S LIBRARY ON 12/08/2022. THE PUMP WAS RETURNED ON 105/15/2024 AND THE INVESTIGATION WAS COMPLETED ON 5/29/2024. THE EVENT LOG OF THE RETURNED DEVICE WAS REVIEWED, AND THERE ARE NO LINES THAT INDICATE AN ABRUPT POWER OFF TOOK PLACE. A 50 ML INFUSION WAS RAN ON THE PUMP INSTEAD OF A 100 ML INFUSION DUE TO A LIMIT IN THE CUSTOMER'S LIBRARY CONFIGURATION. THE INFUSION RAN FOR 50 ML AT A RATE OF .6 ML PER HOUR. THE INFUSION WAS SUCCESSFULLY COMPLETED AND THE PUMP DID NOT POWER OFF ABRUPTLY BEFORE FINISHING. PRESSING THE BOLUS BUTTON DID NOT CAUSE THE PUMP TO POWER OFF, AS REPORTED BY THE END USER. DURING FUNCTIONAL TESTING, THE REPORTED ISSUE WAS NOT DUPLICATED. THERE WAS NO ABURPT POWER OFF PRESENT IN THE EVENT LOG, THE PUMP THEN COMPLETED A 50 ML INFUSION WITHOUT ONE TAKING PLACE. A CAPA HAS BEEN OPENED TO ADDRESS THE ISSUE REPORTED. REF (B)(4).

    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. DEVICE RETURN REQUESTED. THIS MDR WILL BE REOPENED AND UPDATED IN THE EVENT THE DEVICE INVOLVED OR ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 0

    ON (B)(6) 2024, INFUTRONIX RECEIVED A REPORT THAT A PUMP HAD "POWER ISSUE - INTERMITTENT POWERS SELF OFF". THE PUMP KEPT TURNING OFF WHEN SHE USED BOLUS BUTTON. THE INFUSION CANNOT RESUME WITHOUT CAUSING DELAY IN TREATMENT. NO PATIENT HARMED. REQUESTED DEVICE TO BE RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    441160 NIMBUS II PLUS AMBULATORY INFUSION PUMP AMBULATORY INFUSION PUMP FRN INFUTRONIX, LLC NIMBUS II PLUS 2206213120 00817170020161

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown