BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFUSOMAT SPACE

    MDR report key: 17306621 · Received July 12, 2023

    Report

    Report Number
    9610825-2023-00354
    Event Type
    Malfunction
    Date Received
    July 12, 2023
    Date of Event
    August 9, 2022
    Report Date
    October 10, 2023
    Manufacturer
    B.BRAUN MELSUNGEN AG
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    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). AS NO SAMPLE AND NO MEANINGFUL PICTURE WAS PROVIDED, PROPER INVESTIGATION ON MALFUNCTION COULD NOT BE PERFORMED. HENCE, THE COMPLAINT IS CONSIDERED AS NOT CONFIRMED. 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.

    Additional Manufacturer Narrative · 0

    THIS REPORT HAS BEEN IDENTIFIED AS B. BRUAN 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 BYB. BRUAN MEDICAL, INC.

    Description of Event or Problem · 0

    AS REPORTED BY THE USER FACILITY INFORMATION IN AUSTRALIA: "UNDERINFUSION." ACCORDING TO THE CUSTOMER: "THE NEXT REPORTED INCIDENT OCCURRED ON (B)(6), 2022. IT WAS REPORTED THAT A 600ML BAG OF MEDICATION WAS PROGRAMMED TO BE INFUSED OVER 2HRS. AT THE END OF THE 2HR INFUSION, THE BAG WAS FOUND TO HAVE APPROXIMATELY 120MLS REMAINING. AGAIN, 2X UPSTREAM ALARMS WERE SOUNDED IN THE INFUSION PRIOR TO THE REPORTED INCIDENT, AND THE LINE WAS NOT CHANGED BEFORE THE REPORTED INFUSION WAS COMMENCED. NO ALARMS WERE TRIGGERED DURING THE INFUSION UNDER INVESTIGATION."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    802857 INFUSOMAT SPACE PUMP, INFUSION FRN B.BRAUN MELSUNGEN AG

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown