BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFUSOMAT

    MDR report key: 11504939 · Received March 17, 2021

    Report

    Report Number
    9610825-2021-00096
    Event Type
    Malfunction
    Date Received
    March 17, 2021
    Report Date
    August 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 INVESTIGATED IN OUR LABORATORY IN SAO GONCALO, BRAZIL: ACCORDING TO THE ABOVE HISTORY, THE INFUSION TOOK PLACE EXACTLY AS SCHEDULED.

    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 BE SENT FOR AN EXAMINATION AND ROOT CAUSE ANALYSIS IN OUR SERVICE LABORATORY IN (B)(4). A FOLLOW-UP REPORT WILL BE PROVIDED AS SOON AS 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)(4): "UNDER INFUSION / OPERATING UNIT." ACCORDING TO CUSTOMER: "INFUSION PUMP WITH BLOOD COMPONENT. SCHEDULED AT 12:14 PM 293 ML / 2HS WITH FLOW 146.5 ML / H. AT 14:05 PM THE INFUSION PUMP SHOWED ON THE DISPLAY 284 ML OF TOTAL VOLUME INFUSED, BUT THE POUCH APPARENTLY HAD THE VOLUME IN HALF." "

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    401819 INFUSOMAT PUMP, INFUSION FRN B.BRAUN MELSUNGEN AG

    Patients

    Seq Age Sex Outcome Treatment
    1