BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFUSOMAT

    MDR report key: 11271993 · Received February 3, 2021

    Report

    Report Number
    9610825-2021-00018
    Event Type
    Malfunction
    Date Received
    February 3, 2021
    Date of Event
    January 7, 2021
    Report Date
    May 4, 2021
    Manufacturer
    B.BRAUN MELSUNGEN AG
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN MELSUNGEN AG INTERNAL REPORT (B)(4). THE DEVICE WAS PROVIDED FOR AN EXAMINATION AND ROOT CAUSE ANALYSIS IN OUR SERVICE LABORATORY IN SAO GONZALO. THE DEVICE WAS SUBJECTED TO AN INVESTIGATION ACCORDING TO THE TSC TEST (TECHNICAL SERVIE TEST). ALL RESULTS WERE WITHIN SPECIFICATION, THE COMPLAINT WAS NOT CONFIRMED.

    Additional Manufacturer Narrative · 1

    THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN (B)(4) AG INTERNAL REPORT (B)(4). THE DEVICE HAS BEEN REQUESTED TO SEND IT FOR INVESTIGATION TO BBM LABORATORY IN (B)(4). IF AN INVESTIGATION REPORT IS AVAILABLE, A FOLLOW-UP REPORT WILL CREATED. 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)(4): "OVER INFUSION / OPERATING UNIT". CUSTOMER INFORMATION: SOLUTION IS OVER BEFORE THE DEADLINE FOR INFUSION. YOU'D HAVE TO RUN IN 8:00 AND YOU'D RUN IN FOUR HOURS. DATE: (B)(6) 2021 TO (B)(6) 2021. TIME: 19H UNTIL 01H30. SERIAL NUMBER: (B)(4). HERITAGE: UTIC-1133T. PRESCRIBED MEDICINE: DOBUTAMINE 20ML (250MG) SF0.9% 80ML. INFUSION RATE REQUESTED: 5ML/H.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    171431 INFUSOMAT PUMP, INFUSION FRN B.BRAUN MELSUNGEN AG

    Patients

    Seq Age Sex Outcome Treatment
    1