BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFUSOMAT

    MDR report key: 11515412 · Received March 18, 2021

    Report

    Report Number
    9610825-2021-00100
    Event Type
    Malfunction
    Date Received
    March 18, 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 EQUIPMENT'S HISTORY, WE FOUND ONLY A SINGLE 330ML SCHEDULE, ON (B)(6) 2020, AT 13:50:40, COMPATIBLE WITH THE CUSTOMER'S INFORMATION. HOWEVER, THE TOTAL PROGRAMMED INFUSION TIME WAS FROM 5:30 PM TO 1:50:51 PM, RESULTING IN A PROGRAMMED FLOW RATE OF 18.86 ML/H. THE INFUSION TOOK PLACE EXACTLY AS SCHEDULED UNTIL (B)(6) 2020, AT 06:10:28, BY THE USER. THE TOTAL AMOUNT OF DRUG INFUSED WAS 301.39ML. RESULTING IN A TOTAL INFUSION TIME OF 16:18:46. WE VERIFIED IN THE PERIOD ONLY TWO ALARMS THAT WERE INHIBITED IN MINUTES THE EQUIPMENT WORKED AS EXPECTED, THE DEVIATION INFORMATION PROVIDED BY THE CUSTOMER WAS NOT CONFIRMED IN THE OPERATING HISTORY. UNCONFIRMED TECHNICAL COMPLAINT.

    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): "OVERINFUSION". ACCORDING TO CUSTOMER: "AV PATIENT'S NPP ENDED AT 4:30, BUT STARTED TO ALARM AT 4 O'CLOCK AND TOOK THE WHOLE SCHOLARSHIP INSTEAD OF THE 330 SCHEDULE, AND IT WAS ONLY GOING TO END AT 6:40 AM ON THE SCHEDULE." "

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    416215 INFUSOMAT PUMP, INFUSION FRN B.BRAUN MELSUNGEN AG

    Patients

    Seq Age Sex Outcome Treatment
    1