BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFUSOMAT ®

    MDR report key: 19220385 · Received May 1, 2024

    Report

    Report Number
    9610825-2024-00329
    Event Type
    Malfunction
    Date Received
    May 1, 2024
    Date of Event
    December 8, 2023
    Report Date
    July 8, 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 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.

    Additional Manufacturer Narrative · 0

    THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN INTERNAL REPORT NUMBER (B)(4). 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 INFORMATION: D9 DEVICE RETURNED TO MANUFACTURER USE HISTORY THE USAGE HISTORY EXTRACTED FROM THE EQUIPMENT AND SAVED IN AN EXCEL FILE. ANALYSIS OF USE HISTORY THERE IS NO RECORD OF EQUIPMENT USE ON 12/08/2023 IN THE HISTORY. WE CHECK THE LAST PROGRAMMING MADE BY THE USER IN THE HISTORY. THE VOLUME OF 350ML WAS PROGRAMMED FOR A FLOW RATE OF 26.93ML/H ON (B)(6) 2023. THE INFUSION STARTED AT 20:52:56 AND CONCLUDED AT 09:52:51 ON (B)(6) 2023. INFUSED VOLUME OF 350ML, ACCORDING TO THE SCHEDULE. THE PROGRAMMED TIME FOR INFUSION WAS 13 HOURS AND INFUSION TIME WAS 12:59:55. THE USER WAS USING THE SAMARITAN DRUG LIBRARY NPT N01.D. NO EVIDENCE OF INFUSION ERROR WHEN THE EQUIPMENT WAS LAST USED. FUNCTIONAL ANALYSIS THE EQUIPMENT MUST PERFORM THE INFUSION BY COMPLETELY INFUSING THE PROGRAMMED VOLUME. THE INFUSION WAS CARRIED OUT ACCORDING TO THE SCHEDULE AND INFUSED THE ENTIRE PROGRAMMED VOLUME. THE RESULT OF THE FUNCTIONAL TEST SHOWED THAT THE EQUIPMENT IS INFUSING CORRECTLY ACCORDING TO THE PRECISION SPECIFIED FOR IT. VISUAL ANALYSIS: EQUIPMENT APPEARS NORMAL AS USED. CONCLUSION: WHEN EVALUATING THE HISTORY OF USE, NO ERROR IN THE INFUSION VOLUME WAS FOUND. THE RESULT OF THE FUNCTIONAL TEST SHOWED THAT THE EQUIPMENT IS INFUSING CORRECTLY ACCORDING TO THE PRECISION SPECIFIED FOR IT. TECHNICAL COMPLAINT OF INFUSED VOLUME ERROR NOT CONFIRMED.

    Description of Event or Problem · 0

    ACCORDING TO THE COMPLAINANT THE INFUSION PUMP MARKED THAT IT WAS ALL VOLUME OF NPP BUT THERE WAS A LARGE AMOUNT OF NPP LEFT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2137378 INFUSOMAT ® PUMP, INFUSION FRN B BRAUN MELSUNGEN AG 8713050

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown