BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSOMAT

    MDR report key: 20852847 · Received December 5, 2024

    Report

    Report Number
    20852847
    Event Type
    Injury
    Date Received
    December 5, 2024
    Date of Event
    June 9, 2024
    Report Date
    November 26, 2024
    Manufacturer
    B. BRAUN MEDICAL INC.
    Product Code
    FRN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MD
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    PATIENT (PT) ARRIVED AS TRANSFER FROM OTHER HOSPITAL, REQUIRING PRESSORS AND BLOOD PRODUCTS DURING TRANSPORT R/T HYPOTENSION. UPON ARRIVAL, TRANSITIONED TO B BRAUN PUMPS WITH LEVO, VASO AND EPI; MTE INITIATED FOR CONTINUING HYPOTENSION. PRIMARY RN (REGISTERED NURSE) AND ADDITIONAL RN WERE AT BEDSIDE WHEN NOTICED HYPOTENSIVE TO MAP (MEAN ARTERIAL PRESSURES) OF 50S AND DECREASING. UPON INVESTIGATION, LEVO INFUSION HAD TRANSITIONED TO KVO (KEEP VEIN OPEN) WITHOUT AUDIBLE ALARM AND VOLUME STILL LEFT ON PUMP. REQUIRED ADDITIONAL BLOOD PRODUCTS, REPROGRAMMING PUMP AND UPWARD TITRATION OF OTHER VASOACTIVES TO PREVENT FURTHER HYPOTENSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2096299 INFUSOMAT PUMP, INFUSION FRN B. BRAUN MEDICAL INC. 8713051U

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Male Life Threatening| R