BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFUSOMAT®

    MDR report key: 17906763 · Received October 10, 2023

    Report

    Report Number
    9610825-2023-00457
    Event Type
    Malfunction
    Date Received
    October 10, 2023
    Date of Event
    September 1, 2023
    Report Date
    May 1, 2024
    Manufacturer
    B BRAUN MELSUNGEN AG
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN INTERNAL REPORT NUMBER (B)(4). A FOLLOW-UP REPORT WILL BE PROVIDED AFTER THE EXAMINATION RESULTS ARE AVAILABLE. NOTE: THIS REPORT IS BEING FILED FOR AN ITEM NUMBER THAT IS NOT SOLD IN THE UNITED STATES, HOWEVER SIMILAR ITEMS ARE SOLD IN THE UNITED STATES BY B. BRAUN MEDICAL, INC.

    Additional Manufacturer Narrative · 0

    THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN INTERNAL REPORT NUMBER (B)(4). NOTE: THIS REPORT IS BEING FILED FOR AN ITEM NUMBER THAT IS NOT SOLD IN THE UNITED STATES, HOWEVER SIMILAR ITEMS ARE SOLD IN THE UNITED STATES BY B. BRAUN MEDICAL, INC. AS NO SAMPLE AND NO PICTURE WAS PROVIDED FOR INVESTIGATION A MALFUNCTION COULD NOT BE DETECTED AND THEREFORE THE COMPLAINT IS CONSIDERED AS NOT CONFIRMED. THE COMPLAINT IS ONLY TAKEN TO KNOWLEDGE AND FILED FOR STATISTICAL PURPOSES. HOWEVER, IF THE COMPLAINT SAMPLE WILL BE PROVIDED, THE COMPLAINT WILL BE RE-OPENED ACCORDINGLY. THE INVESTIGATION SAMPLE(S) IS/ARE NOT AVAILABLE.

    Description of Event or Problem · 0

    AS REPORTED BY THE USER FACILITY INFORMATION BY BBM SALES ORGANIZATION IN DENMARK: "OVER INFUSION" ACCORDING TO THE CUSTOMER: "THE PUMP IS SET TO 4 ML/H OG A TOTAL VOLUME OF 90 ML AT 00.10 PM - AT 8.15 AM. THE PUMP IS STILL RUNNING 4 ML/H AND THERE IS 54 ML LEFT, BUT THE CONTAINER IS EMPTY. THERE IS NO ALARM FROM THE PUMP REGARDING THE EMPTY CONTAINER. THE PATIENT HAS HAD AN AMOUNT OF 90 ML INSTEAD OF 32 ML."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    331618 INFUSOMAT® PUMP, INFUSION FRN B BRAUN MELSUNGEN AG 8713050

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown