BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFUSOMAT SPACE

    MDR report key: 15751631 · Received November 8, 2022

    Report

    Report Number
    9610825-2022-00462
    Event Type
    Malfunction
    Date Received
    November 8, 2022
    Report Date
    November 10, 2023
    Manufacturer
    B.BRAUN MELSUNGEN AG
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN MELSUNGEN AG INTERNAL REPORT (B)(4): THE COMPLAINT IS UNDER EVALUATION. 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 MELSUNGEN AG INTERNAL REPORT (B)(4). THE DEVICE HAS BEEN INVESTIGATED IN OUR SERVICE DEPARTMENT AT LABORATÓRIOS B.BRAUN S.A., SÃO GONÇALO, BRAZIL: AS THE USER DID NOT PROVIDE THE NECESSARY INFORMATION TO CARRY OUT THE INVESTIGATION, WE EXTRACTED THE EQUIPMENT USAGE HISTORY AND SAVED THE DATA FOR FURTHER CONSULTATION IN CASE THE USER MAKES THE INFORMATION AVAILABLE IN THE FUTURE. IN THE FUNCTIONAL TEST WE FOUND THAT THE EQUIPMENT IS WORKING CORRECTLY.

    Description of Event or Problem · 0

    AS REPORTED BY THE USER FACILITY INFORMATION BY BBM SALES ORGANIZATION IN BRAZIL: "UNDERINFUSION" CUSTOMER STATEMENT: "THERE WAS A PROBLEM IN INFUSION RATE, THE VTBI FINISHED AND THE DRUG WAS FULL."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2548447 INFUSOMAT SPACE PUMP, INFUSION, FRN B.BRAUN MELSUNGEN AG

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown