BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFUSOMAT SPACE

    MDR report key: 15681189 · Received October 27, 2022

    Report

    Report Number
    9610825-2022-00442
    Event Type
    Malfunction
    Date Received
    October 27, 2022
    Report Date
    August 8, 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 NUMBER (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: THE USER DID NOT INFORM THE DATE ON WHICH THE ADVERSE EVENT OCCURRED. WE FOUND 04 ENTRIES OF 10 HOURS OF INFUSION IN THE SCHEDULE ON (B)(6) 2022, LET'S CONSIDER THE LAST ONE, AS IT REPLACED THE OTHERS. AT 15:02:40. HOWEVER, AFTER PERFORMING THIS PROGRAMMING, THE USER ENTERED SEVERAL OTHER SPECIFIC VOLUME AND FLOW SCHEDULES AND IN DOING SO, THE EQUIPMENT CORRECTLY RECALCULATED THE INFUSION TIME ACCORDING TO THE SELECTED FLOW AND VOLUME SCHEDULES. WITH INFUSION TIMES DIFFERENT FROM THE 10 HOURS INITIALLY PROGRAMMED, BUT AT THE USER'S OWN OPTION. WE PERFORMED A FUNCTIONAL TEST BY PROGRAMMING A TIME OF 10 HOURS FOR A VOLUME OF 100ML. TIMED: 10 HOURS - INFUSED AT: 10 HOURS - ERROR: 0%. PROGRAMMED: 100 ML - INFUSED: 105 ML - ERROR: 5%. RESULT: APPROVED. USAGE HISTORY AND FUNCTIONAL TESTING INDICATE THAT THE EQUIPMENT IS WORKING PROPERLY. TECHNICAL COMPLAINT NOT CONFIRMED. 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 INFUSION PUMP WAS PROGRAMMED TO INFUSE DURING 10 HOURS AND THE TOTAL VOLUME INFUSED IN ONLY 4 HOURS."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2510866 INFUSOMAT SPACE PUMP, INFUSION, FRN B.BRAUN MELSUNGEN AG

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown