BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFUSOMAT

    MDR report key: 11378934 · Received February 25, 2021

    Report

    Report Number
    9610825-2021-00050
    Event Type
    Malfunction
    Date Received
    February 25, 2021
    Date of Event
    January 26, 2021
    Report Date
    May 5, 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 HISTORY DATA WAS INVESTIGATED IN OUR LABORATY IN SAO GONCALO, BRAZIL: THE DEVICE HISTORY WAS ANALYZED. NO ABNORMALITIES WERE FOUND IN THE DEVICE HISTORY. BASED ON THE PROVIDED INFORMATION, THE COMPLAINT IS CONSIDERED AS NOT CONFIRMED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE HAS BEEN REQUESTED TO SEND IT FOR INVESTIGATION TO BBM LABORATORY. 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)(6): "OVERINFUSION". CUSTOMER INFORMATION: "REASON OF COMPLAINT: ACCORDING TO CUSTOMER: "INFUSION PUMP IN QUESTION ACCORDING TO NURSING INFUSED ON THE DAY (B)(6) 2021 120ML IN 1H33MIN, AND 60ML / H WAS PROGRAMMED, FOR CONSEQUENCE SHOULD HAVE INFUSED IN 2 HOURS. WE REQUEST VERIFICATION OF THE SAME."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    278795 INFUSOMAT PUMP, INFUSION FRN B.BRAUN MELSUNGEN AG

    Patients

    Seq Age Sex Outcome Treatment
    1