BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFUSOMAT SPACE

    MDR report key: 15047257 · Received July 18, 2022

    Report

    Report Number
    9610825-2022-00285
    Event Type
    Malfunction
    Date Received
    July 18, 2022
    Report Date
    July 24, 2023
    Manufacturer
    B.BRAUN MELSUNGEN AG
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    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.

    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: USER REPORTED AN INFUSION ERROR OF 12.5%. HOWEVER, IT DID NOT INFORM THE DAY OF THE OCCURRENCE OR THE PROGRAMMED INFUSION PARAMETERS. WE CHECKED THE HISTORY FOR THE LAST SCHEDULE FOR 24 HOURS OF INFUSION AND CALCULATED AN ACCEPTABLE ERROR OF 3.2% IN INFUSION TIME ENDING AND 2.7% IN INFUSED VOLUME. THUS, ACCORDING TO THE HISTORY, THE INFUSION TOOK PLACE AS SCHEDULED. ON (B)(6) 2022, ANOTHER INFUSION WAS PROGRAMMED WITH THE SAME PARAMETERS; BUT IT WAS TERMINATED BY THE USER BEFORE INFUSING THE ENTIRE PROGRAMMED VOLUME. THE USER HAS PROGRAMMED THE VOLUME OF 1681ML FOR A FLOW RATE OF 70.05ML/H TO OCCUR IN 24 HOURS. HOWEVER, THE USER STOPPED THE INFUSION 05 HOURS AND 11 MINUTES BEFORE, AFTER THE VOLUME OF 1314.60 ML HAD BEEN INFUSED, A VALUE COMPATIBLE WITH THE TOTAL INFUSION TIME. THUS, ACCORDING TO THE HISTORY, THE INFUSION TOOK PLACE AS SCHEDULED. ON (B)(6) 2022, ANOTHER INFUSION WAS PROGRAMMED WITH THE SAME PARAMETERS; BUT, IT WAS TERMINATED BY THE USER BEFORE INFUSING THE ENTIRE PROGRAMMED VOLUME. THE USER HAS PROGRAMMED THE VOLUME OF 1681ML FOR A FLOW RATE OF 70.05ML/H TO OCCUR IN 24 HOURS. HOWEVER, THE USER STOPPED THE INFUSION 05 HOURS AND 11 MINUTES BEFORE, AFTER THE VOLUME OF 1314.60 ML HAD BEEN INFUSED, A VALUE COMPATIBLE WITH THE TOTAL INFUSION TIME. THUS, ACCORDING TO THE HISTORY, THE INFUSION TOOK PLACE AS SCHEDULED. AFTER ANALYSIS OF USAGE HISTORY AND FUNCTIONAL TESTING. WE CONSIDER THE TECHNICAL COMPLAINT UNCONFIRMED. 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: "OVERINFUSION" ACCORDING TO THE CUSTOMER: "THE PUMP WAS PROGRAMMED TO INFUSE NPP WITHIN 24 HOURS AND IT INFUSED FULL VOLUME 3 HOURS BEFORE OF THE TIME. (IT STARTED AT 20 PM AND ENDED AT 17:00 PM)".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    241471 INFUSOMAT SPACE PUMP, INFUSION FRN B.BRAUN MELSUNGEN AG

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown