BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS

    MDR report key: 7493911 · Received May 8, 2018

    Report

    Report Number
    7493911
    Event Type
    Malfunction
    Date Received
    May 8, 2018
    Date of Event
    October 5, 2017
    Report Date
    May 3, 2018
    Manufacturer
    CAREFUSION 303, INC.
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    NURSE PROGRAMMED PUMP TO START LEVOPHED GTT (DROPS). EVERYTHING WAS SET UP APPROPRIATELY AND ONCE THE TUBING WAS PLACED INTO THE CHANNEL AND THE DOOR WAS CLOSED THE GTT WAS GOING WIDE OPEN INSTEAD OF THE SET RATE THAT WAS PROGRAMMED. AS A RESULT, THE PATIENT'S BLOOD PRESSURE WAS AS HIGH AS SBP 248, NIRPRIDE STARTED AND PT THEN BECAME HYPOTENSIVE REQUIRING FLUID. PUMP TAKEN OUT OF ROOM AND TAGGED DO NOT USE. PT ADMITTED FROM OPERATING ROOM (OR), LEVOPHED NEEDED FOR HYPOTENSION. ONCE IT WAS STARTED, PT BECAME HYPERTENSIVE AND REQUIRED NIPRIDE AND THUS BECAME HYPOTENSIVE. PATIENT'S BLOOD PRESSURE LABILE FOR THE REMAINDER OF THE SHIFT ALONG WITH THE FOLLOWING SHIFT. PHYSICIAN AWARE AND TOOK PT BACK TO OR WHERE HE WAS REOPENED AND REMOVED 3.5L FROM CHEST. CAREFUSION/BD CORP, INFUSION CONTROLLER, MODEL # 8015. CAREFUSION/BD CORP. PUMP MODULE, MODEL# 8100.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    339491 ALARIS PUMP, INFUSION FRN CAREFUSION 303, INC. 8100

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Other