BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    B. BRAUN INFUSION PUMP

    MDR report key: 21595752 · Received March 13, 2025

    Report

    Report Number
    MW5167643
    Event Type
    Malfunction
    Date Received
    March 13, 2025
    Date of Event
    November 13, 2024
    Report Date
    March 10, 2025
    Manufacturer
    B. BRAUN MEDICAL INC.
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    RISK MANAGER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    (B)(6) 2024, 1:30 PM BY RISK, RDE--- WHEN SCANNING A NEW BAG OF LEVOPHED AND THEN SCANNING THE B. BRAUN PUMP, WE WENT TO CHANGE THE VOLUME OF THE BAG BEFORE ACCEPTING THE INFORMATION THE PUMP GAVE US. THE PUMP THEN GAVE AN ERROR WARNING AND STOPPED INFUSING. THIS PATIENT ALREADY HAD LEVOPHED INFUSING AT .2 MCG/KG/MIN AND THE INFUSION WASN'T RUNNING WHILE THE PUMP WAS IN ERROR MODE, AND THEN IN THE SUBSEQUENT MINUTES THAT WE WERE TRYING TO RE-SCAN AND TROUBLESHOOT TO GET IT TO START RUNNING AGAIN. EVENTUALLY, WE HAD TO PUT THE INFUSION ON A DIFFERENT PUMP. THIS B. BRAUN MALFUNCTION WAS EXTREMELY DANGEROUS. LUCKILY, THE PATIENT DID NOT BECOME UNSTABLE DURING THIS EVENT, BUT CERTAINLY COULD HAVE, AS THE DOSE THAT WAS STOPPED BY THE ERROR IS PRETTY SIGNIFICANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1986712 B. BRAUN INFUSION PUMP PUMP, INFUSION FRN B. BRAUN MEDICAL INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Female