BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NIMBUS II FLEX

    MDR report key: 8693104 · Received June 12, 2019

    Report

    Report Number
    3011581906-2019-00017
    Event Type
    Malfunction
    Date Received
    June 12, 2019
    Date of Event
    May 16, 2019
    Report Date
    May 16, 2019
    Manufacturer
    INFUTRONIX, LLC
    Product Code
    FRN
    UDI-DI
    00817170020093
    PMA / PMN Number
    K153193
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED ISSUE WAS CONFIRMED. PUMP EVENT LOG HISTORY SHOWED MULTIPLE UPSTREAM OCCLUSION ALERTS. DUE TO THE UPSTREAM OCCLUSION PRESENCE IN THE EVENT LOG, FORCEPS WERE CLAMPED ONTO THE TUBING DURING THIS TESTING TO TRIGGER UPSTREAM OCCLUSION ALERT AND THEN PUMP WAS ABLE TO SUCCESSFULLY SENSE PRESSURE RELIEF AND RESUME INFUSION WHEN FORCEPS WERE UNCLAMPED. IN ORDER TO TEST FOR FLOWRATE, THE PUMP WAS PROGRAMMED WITH A 24HR INFUSION WHERE IT YIELDED RESULTS OF -6.3% FLOWRATE ACCURACY AND ANOTHER INFUSION PROGRAMMED FOR 46HRS WITH THE RESULTS -5.15% FLOWRATE ACCURACY. THE PUMP WAS RAN THROUGH EVALUATION TESTING WITH FLOW RATE ACCURACY OUTSIDE SPECIFICATION DURING BOTH INFUSION TESTS. ALTHOUGH THIS IS NOT AS WIDE A DEVIATION AS REPORTED, A FLOW RATE ISSUE ON THE PUMP HAS BEEN CONFIRMED. THE DEVICE WAS REMOVED FROM SERVICE.

    Description of Event or Problem · 0

    THIS IS A FOLLOW-UP FOR THE INITIALLY FILED MDR (3011581906-2019-00017).

    Additional Manufacturer Narrative · 1

    THE AFFECTED DEVICE WAS RETURNED TO THE DISTRIBUTOR ON 05/21/2019. THE DEVICE IS UNDER TESTING BY A SERVICE PROVIDER OF INFUTRONIX. THE MANUFACTURER INFORMATION LISTED IN MEDWATCH REPORT #MW5086951 WAS IDENTIFED AS "ZYNO MEDICAL LLC". THIS IS INCORRECT, AND THE MANUFACTURER NAME SHOULD BE INFUTRONIX LLC.

    Description of Event or Problem · 1

    INFUTRONIX RECEIVED AN UNDER-INFUSION ISSUE OF THE DEVICE FROM A DISTRIBUTOR ON (B)(6) 2019 THAT "PUMP 300842 WAS SET FOR A 46 HOUR INFUSION FOR AN INITIAL RESERVOIR VOLUME OF 100ML. THE SCREEN SHOWED THAT THERE WAS 1.4ML LEFT IN THE RESERVOIR, BUT IN REALITY HAD 42ML REMAINING. NO PATIENT WAS HARMED. DEVICE OPERATOR TITLE UNKNOWN. MEDICATION 5FU." NO OTHER PATIENT INFORMATION WAS PROVIDED TO INFUTRONIX. ON (B)(4) 2019, INFUTRONIX RECEIVED A LETTER FROM THE FDA REGARDING MEDWATCH REPORT (REPORT #MW5086951). THE DESCRIPTION IS AS THE FOLLOWING: "THE PATIENT CAME IN FOR DISCONNECTION AND THE NURSE NOTICED THAT CHEMO WAS STILL IN THE BAG. FORTY TWO MILLILITERS WERE LEFT IN THE BAG".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    484484 NIMBUS II FLEX AMBULATORY INFUSION PUMP FRN INFUTRONIX, LLC NIMBUS II FLEX 180402360 00817170020093

    Patients

    Seq Age Sex Outcome Treatment
    1