BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALARIS

    MDR report key: 12672351 · Received October 21, 2021

    Report

    Report Number
    12672351
    Event Type
    Injury
    Date Received
    October 21, 2021
    Date of Event
    August 11, 2021
    Report Date
    September 30, 2021
    Manufacturer
    CAREFUSION 303, INC.
    Product Code
    FRN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NY
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    50 ML BOTTLE OF PROPOFOL INFUSION APPEARED TO BE INFUSING TO QUICKLY, INFUSED IN 1 HOUR WHEN DOSE WAS 30 MCG/KG/MIN OR 19.5 ML/HR FOR 108.2 KG PATIENT. MANUFACTURER RESPONSE FOR ALARIS PUMP, ALARIS PUMP (PER SITE REPORTER): UNKNOWN AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1573418 ALARIS PUMP, INFUSION FRN CAREFUSION 303, INC. 8100

    Patients

    Seq Age Sex Outcome Treatment
    1 17885 DA