BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFUSOMAT

    MDR report key: 11977338 · Received June 10, 2021

    Report

    Report Number
    9610825-2021-00228
    Event Type
    Malfunction
    Date Received
    June 10, 2021
    Date of Event
    May 21, 2021
    Report Date
    August 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 WAS INVESTIGATED IN OUR LABORATORY IN SAO GONZALO, BRAZIL: ON (B)(6) 2021 THE FLOW RATE OF 288ML/H WAS NOT PROGRAMMED. BUT WE FOUND A SCHEDULE WITH AN APPROXIMATE VALUE OF 280ML/H, AT 15:48:56, FOR A VOLUME OF 560ML, TO OCCUR IN 02 HOURS. THE HISTORY SHOWS THAT THE SCHEDULE HAPPENED EXACTLY AS PER THE SCHEDULE". "AS THE CUSTOMER REPORTED THAT THE EQUIPMENT DID NOT INFUSE THE DRUG, WE SIMULATED AN INFUSION USING THE SAME PARAMETERS FOUND IN THE USAGE HISTORY AND THE EQUIPMENT WORKED PERFECTLY AS EXPECTED.

    Additional Manufacturer Narrative · 1

    THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN MELSUNGEN AG INTERNAL REPORT (B)(4).THE COMPLAINT IS UNDER EVALUATION. 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.

    Description of Event or Problem · 1

    AS REPORTED BY THE USER FACILITY INFORMATION BY BBM SALES ORGANIZATION IN (B)(6): "UNDERINFUSION" ACCORDING TO THE CUSTOMER: "THE CUSTOMER REPORTS THAT THE PUMP WAS PROGRAMMED FOR 2 HOURS, WITH OXALIPLATIN MEDICINE, WITH A FLOW RATE OF 288ML/H, BUT THE MEDICATION HAS NOT BEEN INFUSED. THE CUSTOMER INFORMS THAT THIS FACT OCCURRED ON (B)(6) 2021."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    870929 INFUSOMAT PUMP, INFUSION FRN B.BRAUN MELSUNGEN AG

    Patients

    Seq Age Sex Outcome Treatment
    1