BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFUSOMAT®

    MDR report key: 18491707 · Received January 11, 2024

    Report

    Report Number
    9610825-2023-00678
    Event Type
    Malfunction
    Date Received
    January 11, 2024
    Report Date
    April 12, 2024
    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 MEDICAL INTERNAL REPORT NUMBER (B)(4). USE HISTORY: UNABLE TO EXTRACT USAGE HISTORY. THE EQUIPMENT'S MOTHERBOARD IS DAMAGED. ANALYSIS OF USE HISTORY: NOT APPLICABLE. FUNCTIONAL ANALYSIS: INFUSION PERFORMANCE TEST: PROGRAMMED FLOW: 4.17 ML/H PROGRAMMED TIME: 24H00MIN RESULTING VOLUME: 100ML INFUSED VOLUME: 101ML ERROR: +1.0% (APPROXIMATE VOLUME FOR MORE) INFUSION TIME: 23:58:53 ERROR: -0.1% RESULT: APPROVED VISUAL ANALYSIS: EQUIPMENT APPEARS NORMAL AS USED. CONCLUSION: AS THE EQUIPMENT'S MOTHERBOARD IS DAMAGED, IT WAS NOT POSSIBLE TO EXTRACT THE USAGE HISTORY TO ANALYZE IT. THE USER'S COMPLAINT WAS THAT AFTER 24 HOURS OF INFUSION, THE MEDICINE BAG REMAINED FULL. WE UNDERSTAND THAT THE COMPLAINT IS THAT THE EQUIPMENT IS NOT PERFORMING THE PROGRAMMED INFUSION. IN THE PERFORMANCE TEST, WE PROGRAMMED A VOLUME OF 100ML TO BE INFUSED IN 24 HOURS, WITH A RESULTING FLOW RAT OF 4.17ML/H. THE TEST RESULT SHOWED THAT HT EQUIPMENT IS INFUSING CORRECTLY PRECISELY ACCORDING TO PROGRAMMING. TECHNICAL COMPLAINT THAT THE EQUIPMENT DOES NOT INFUSE WAS 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.

    Additional Manufacturer Narrative · 0

    THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN INTERNAL REPORT NUMBER (B)(4). 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: "UNDER INFUSION / OPERATING UNIT". ACCORDING TO THE COMPLAINANT THE PATIENT WAS INFUSED 24 HOURS OF PARENTERAL NUTRITION THERAPY, BUT THE BAG WAS FULL AT THE END.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    731915 INFUSOMAT® PUMP, INFUSION FRN B BRAUN MELSUNGEN AG 8713050

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown