BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFUSOMAT SPACE

    MDR report key: 17280209 · Received July 7, 2023

    Report

    Report Number
    9610825-2023-00317
    Event Type
    Malfunction
    Date Received
    July 7, 2023
    Date of Event
    May 31, 2023
    Report Date
    October 5, 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 DEVICE HAS BEEN INVESTIGATED IN OUR SERVICE DEPARTMENT AT LABORATÓRIOS B.BRAUN S.A., SÃO GONÇALO, BRAZIL: THE INFUSION WAS STARTED BY THE USER AT 17:59:11, ON 05/30/2023. AND IT WAS COMPLETED BY THE USER AT 06:54:25 ON (B)(6) 2023. TOTAL INFUSION TIME 12H55MIN14. INFUSED VOLUME 565.24ML. RESULTS COMPATIBLE WITH THE INFUSION PERFORMED. TO VERIFY THE PERFORMANCE OF THE EQUIPMENT, WE PERFORM A FUNCTIONAL TEST USING THE INFORMATION PROVIDED BY THE USER. THERE IS NO EVIDENCE OF INFUSION ERROR IN THE HISTORY OF EQUIPMENT USE. THE RESULT OF THE FUNCTIONAL TEST INDICATES THAT THE EQUIPMENT IS WORKING ACCORDING TO THE ACCURACY SPECIFIED FOR IT. UNCONFIRMED TECHNICAL COMPLAINT. 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 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.

    Description of Event or Problem · 0

    AS REPORTED BY THE USER FACILITY INFORMATION BY BBM SALES ORGANIZATION IN BRAZIL: "OVER INFUSION / OPERATING UNIT". ACCORDING TO THE CUSTOMER: "CHILD USING DAILY NPT, INSTALLED AT 6 PM ON 05/30, PROGRAMMED 700ML IN 16 HOURS, PERFORMED A DOUBLE CHECK WITH THE MOTHER. NPT ENDED 3 HOURS BEFORE SCHEDULE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2015476 INFUSOMAT SPACE PUMP, INFUSION FRN B.BRAUN MELSUNGEN AG

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown