BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFUSOMAT

    MDR report key: 11916248 · Received June 1, 2021

    Report

    Report Number
    9610825-2021-00198
    Event Type
    Malfunction
    Date Received
    June 1, 2021
    Report Date
    June 1, 2021
    Manufacturer
    B.BRAUN MELSUNGEN AG
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN (B)(4) INTERNAL REPORT (B)(4). THE DEVICE HAS BEEN REQUESTED TO BE SENT FOR INVESTIGATION IN OUR SERVICE LABORATORY IN BBM, (B)(4). A FOLLOW-UP REPORT WILL BE PROVIDED AS SOON AS THE INVESTIGATION 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 · 1

    AS REPORTED BY THE USER FACILITY INFORMATION BY BBM SALES ORGANIZATION IN (B)(6): "RATE NOT OK". ACCORDING TO CUSTOMER: "ACCORDING TO THE MEDICAL TECHNOLOGY DEPARTMENT, THERE WAS NO PATIENT HARM AND ALSO NO INFORMATION ABOUT WHETHER THERE WAS AN OVER- OR UNDER-INFUSION".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    810657 INFUSOMAT PUMP, INFUSION FRN B.BRAUN MELSUNGEN AG

    Patients

    Seq Age Sex Outcome Treatment
    1