BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFUSOMAT SPACE

    MDR report key: 16681714 · Received April 5, 2023

    Report

    Report Number
    9610825-2023-00092
    Event Type
    Malfunction
    Date Received
    April 5, 2023
    Date of Event
    January 24, 2023
    Report Date
    August 30, 2023
    Manufacturer
    B.BRAUN MELSUNGEN AG
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    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. 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.

    Additional Manufacturer Narrative · 0

    THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN MELSUNGEN AG INTERNAL REPORT (B)(4). NO PUMP WAS SENT FOR INVESTIGATION. ACCORDING TO THE FAILURE DESCRIPTION, THE WRONG DOSE WAS GIVEN. USER ERROR. 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 · 0

    AS REPORTED BY THE USER FACILITY INFORMATION BY BBM SALES ORGANIZATION IN DENMARK: "UNDERINFUSION." CUSTOMER STATEMENT: "AN INCIDENT WITH A PUMP THAT STOP BEFORE ALL LIQUID HAVE RUN THRUGH. BAG IS EMPTY BUT TUBE IS STILL FULL. PUMP INDICATES WRONG DOSAGE. RATE IS 3.07, VTBI IS 6.7, I.E. AN ADDITIONAL 6.7 ML MUST BE GIVEN. REMAINING TIME IS 2 H AND 11 MIN AND THAT THERE IS ALREADY ADMINISTERED 2.5 ML. INFUSION HAVE LASTED 48 MINUTES. PUMP HAVE BEEN CHECKED BY LOCAL HOSPITAL TECHNICIAN IN NOV 22."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1211743 INFUSOMAT SPACE PUMP, INFUSION, FRN B.BRAUN MELSUNGEN AG

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown