BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS

    MDR report key: 9834657 · Received March 16, 2020

    Report

    Report Number
    9834657
    Event Type
    Malfunction
    Date Received
    March 16, 2020
    Date of Event
    February 17, 2020
    Report Date
    March 6, 2020
    Manufacturer
    CAREFUSION 303, INC.
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    PA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    THIS RN WITNESSED BY A 2ND RN NOTICED WHILE DISCONTINUING A PATIENT-CONTROLLED ANALGESIA MEDICATION THAT THE PUMP HAD DELIVERED MORE VOLUME THAN THE ORDERED AMOUNT. THIS RN WITH 2ND RN CHECKED THE SETTINGS ON THE PUMP WHICH WAS ALL NOTED TO BE CORRECT AND MATCHING THE CURRENT ORDER. PATIENT CLINICAL ASSESSMENT STABLE AND UNCHANGED. VITAL SIGNS UNCHANGED. HEMATOLOGY/ONCOLOGY, ACUTE PAIN, AND UNIT MANAGER WERE ALL MADE AWARE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    297341 ALARIS PUMP, INFUSION FRN CAREFUSION 303, INC. 8120

    Patients

    Seq Age Sex Outcome Treatment
    1 7665 DA