BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NIMBUS II FLEX

    MDR report key: 8693113 · Received June 12, 2019

    Report

    Report Number
    3011581906-2019-00018
    Event Type
    Malfunction
    Date Received
    June 12, 2019
    Date of Event
    May 17, 2019
    Report Date
    May 17, 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 NOT 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 FLOW RATE, THE PUMP WAS PROGRAMMED WITH A 24HR INFUSION WHERE IT YIELDED RESULT OF -4.2% FLOW RATE ACCURACY AND ANOTHER INFUSION PROGRAMMED FOR 46HRS WITH THE RESULTS -0.45% FLOW RATE ACCURACY. THE PUMP WAS RUN THROUGH EVALUATION TESTING WITH FLOW RATE ACCURACY WITHIN THE SCOPE OF OUR SPECIFICATIONS DURING BOTH INFUSION TESTS. THE DEVICE FUNCTIONED AS INTENDED.

    Description of Event or Problem · 0

    THIS IS A FOLLOW-UP FOR THE INITIALLY FILED MDR (3011581906-2019-00018).

    Additional Manufacturer Narrative · 1

    THE AFFECTED DEVICE HAS BEEN RETURNED TO THE DISTRIBUTOR ON 05/23/2019 AND IS CURRENTLY UNDERGOING TESTING BY THE SERVICE PROVIDER. CORRECTION: THE MANUFACTURER INFORMATION LISTED IN MEDWATCH REPORT #MW5086954 WAS IDENTIFIED AS "ZYNO MEDICAL LLC". THIS IS INCORRECT, AND THE MANUFACTURER NAME SHOULD BE INFUTRONIX LLC.

    Description of Event or Problem · 1

    ON 06/10/2019, INFUTRONIX RECEIVED A LETTER FROM THE FDA REGARDING MEDWATCH REPORT (REPORT #MW5086954). THE DESCRIPTION IS AS THE FOLLOWING: "PER FACILITY PATIENT CAME IN FOR DISCONNECTION ON NIMBUS PUMP. THERE WERE 20 ML OF CHEMO REMAINING IN THE PUMP'S BAG. THE PATIENT SAID THAT THE PUMP SHUT OFF BY ITSELF WHICH ALLOWED HER TO THINK THAT ALL OF THE CHEMO WAS GIVEN. THE BATTERY WAS REPLACED ON MAY 15TH BEFORE THE PATIENT WAS CONNECTED. THE INITIAL RESERVOIR WAS 100 ML OVER 46 HOURS. WHEN OUR SUPERVISOR TURNED THE PUMP ON, THE SCREEN WAS SHOWING THAT THE TREATMENT HAD BEEN COMPLETED". ON 06/11/2019, INFUTRONIX RECEIVED THE INITIAL INFORMATION FROM A DISTRIBUTOR OF THE SAME ISSUE. THE DISTRIBUTOR RECEIVED THE FOLLOWING INFORMATION FROM A USER FACILITY REPRESENTATIVE ON (B)(6) 2019: "A PATIENT CAME BACK TODAY SAYING THAT HER PUMP (B)(4) HAD SHUT OFF BY ITSELF WHICH ALLOWED HER TO THINK THAT ALL OF THE CHEMO HAD BEEN INFUSED. THERE WERE 20 ML OF CHEMO REMAINING IN THE PUMP'S BAG. THE BATTERY HAD BEEN REPLACED ON (B)(6) 2019 BEFORE THE PATIENT WAS CONNECTED". NO OTHER PATIENT INFORMATION WAS PROVIDED. NO MEDICATION INFORMATION WAS PROVIDED IN THIS REPORT. NO PATIENT INJURY OR HARM OCCURRED FOR THIS CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    484752 NIMBUS II FLEX AMBULATORY INFUSION PUMP FRN INFUTRONIX, LLC NIMBUS II FLEX 180402360 00817170020093

    Patients

    Seq Age Sex Outcome Treatment
    1