BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFUSOMAT®

    MDR report key: 20857002 · Received December 5, 2024

    Report

    Report Number
    9610825-2024-00868
    Event Type
    Malfunction
    Date Received
    December 5, 2024
    Date of Event
    October 8, 2024
    Report Date
    December 5, 2024
    Manufacturer
    B BRAUN MELSUNGEN AG
    Product Code
    FRN
    UDI-DI
    04046963716752
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN INTERNAL REPORT NUMBER (B)(4). 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 · 0

    ACCORDING TO THE EVENT DESCRIPTION: THERE WAS A POSSIBLE FAILURE IN THE INFUSION OF MEDICATIONS IN A SHORTER TIME THAN SCHEDULED. PRESCRIBED MORPHINE 1.6 MILLILITERS AN HOUR (ML/H), INFUSED AT 9 MILLILITERS AN HOUR (ML/H). NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2289727 INFUSOMAT® PUMP, INFUSION FRN B BRAUN MELSUNGEN AG 04046963716752

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown