BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFUSOMAT®

    MDR report key: 19172633 · Received April 24, 2024

    Report

    Report Number
    9610825-2024-00295
    Event Type
    Malfunction
    Date Received
    April 24, 2024
    Date of Event
    February 27, 2024
    Report Date
    November 15, 2024
    Manufacturer
    B. BRAUN AVITUM AG
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN MEDICAL INTERNAL REPORT NUMBER (B)(4) THE INVESTIGATION IS ONGOING AT THIS TIME. A FOLLOW UP WILL BE SUBMITTED WHEN THE INVESTIGATION RESULTS BECOME AVAILABLE.

    Additional Manufacturer Narrative · 0

    THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN MEDICAL INTERNAL REPORT NUMBER (B)(4). THE DEVICE INVOLVED AND/OR LOGS WERE NOT PROVIDED FOR EVALUATION. THE REPORTED DEFECT WAS NOT CONFIRMED. ALL INFORMATION CONCERNING THIS REPORTED INCIDENT HAS BEEN INCLUDED IN OUR TREND ANALYSIS OF THE PRODUCT LINE.

    Description of Event or Problem · 0

    AS REPORTED BY THE USER FACILITY: ACCORDING TO THE COMPLAINANT, AROUND 0500, THE BEDSIDE NURSE CALLED THE RESOURCE NURSE TO BEDSIDE AND REPORTED THAT THE PATIENT'S GLUCOSE WAS IN THE 500'S. UPON ARRIVAL, THE IV PUMP WAS BEEPING WITH KEEP VEIN OPEN (KVO) DISPLAYED. WHILE ATTEMPTING TO RESET, THE RESOURCE NURSE NOTED THAT THE RATE WAS SET IN THE 30'S. AT THIS POINT, THE RESOURCE NURSE REALIZED THAT MORE FLUID WAS GONE THAN SHOULD HAVE BEEN. THE RATE WAS SUPPOSED TO BE 6.7 MILLILITERS (ML) PER HOUR (HR) FOR 24 HOURS. THE BAG WAS HUNG AT 2205 WITH A VOLUME TO BE INFUSED (VTBI) OF 161.4 ML. AT 0600, THE TOTAL VOLUME INFUSED SHOULD HAVE BEEN 53.6 ML.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    948420 INFUSOMAT® PUMP, INFUSION FRN B. BRAUN AVITUM AG

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown