BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFUSOMAT SPACE

    MDR report key: 17280123 · Received July 7, 2023

    Report

    Report Number
    9610825-2023-00316
    Event Type
    Malfunction
    Date Received
    July 7, 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 USAGE HISTORY EXTRACTED FROM THE EQUIPMENT AND SAVED IN FILES IN EXCEL FORMAT, WAS SAVED IN PDF FORMAT. USER INFORMATION: DATE OF OCCURRENCE NOT INFORMED. FLOW 3ML/H, VOLUME 80ML, TO OCCUR IN MORE THAN 26 HOURS. IT STARTED AT 01:00 AND ENDED AT 06:00. THE DRUG WAS SCHEDULED ON (B)(6) 2023, AT 00:34:59. AT 00:35:08 THE VOLUME OF 80ML WAS PROGRAMMED. AT 00:36:22 A FLOW RATE OF 1ML/H WAS PROGRAMMED. THE INFUSION WAS STARTED AT 00:37:04. AT 06:21:36 THE USER CHANGED THE FLOW RATE TO 2ML/H. AT 06:22:54 THE USER CHANGED THE FLOW RATE TO 3ML/H. AT 16:05:17 THE VOLUME OF 80ML WAS PROGRAMMED. THE AMOUNT ALREADY INFUSED, WHICH WAS NOT RESET BY THE USER, WAS 38.81ML. AT 17:57:42, THE VOLUME OF 75.4 ML WAS PROGRAMMED. ON (B)(6) 2023, THE INFUSION WAS STOPPED BY THE USER AT 09:56:12, THE TOTAL VOLUME INFUSED WAS 92.35ML. INFUSION OCCURRED EXACTLY AS PROGRAMMED BY THE USER. 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: "PATIENT USING FENTANYL 3ML/H, SOLUTION CHANGED AT 01H, TOTAL VOLUME 80ML, CHARGED THE SOLUTION AT 06H."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2055366 INFUSOMAT SPACE PUMP, INFUSION FRN B.BRAUN MELSUNGEN AG

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown