BEUDAMED
    FDA Adverse Event Death Summary report: N

    ALARIS SYSTEMS ASENA GH SYRINGE DRIVER

    MDR report key: 15673292 · Received October 25, 2022

    Report

    Report Number
    MW5112836
    Event Type
    Death
    Date Received
    October 25, 2022
    Date of Event
    July 28, 2012
    Report Date
    October 24, 2022
    Manufacturer
    CAREFUSION 2200, INC.
    Product Code
    FRN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    UK
    Reporter Occupation
    UNKNOWN
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    SODIUM CHLORIDE 9% MADE UP TO 48 MLS IN TOTAL TO A SUBCUTANEOUS INFUSION OF 10 MG OF MIDAZOLAM AND 500 MCG OF ALFENTANIL. INFUSED AT 2 ML AN HOUR FOR 24 HOURS. THE PATIENT WAS NOT KEPT COMFORTABLE AND WAS SUFFERING FROM TERMINAL DELIRIUM AND THE TONGUE BECAME SWOLLEN. THE PATIENT ALSO HAD CONGESTIVE HEART FAILURE, RENAL FAILURE AND HEPATIC ISSUES. EDEMA, HYPERTENSIVE. GIVEN SUBCUTANEOUSLY IN A ALARIS SYSTEMS ASENA GH SYRINGE DRIVER WHICH I DO NOT BELIEVE WAS THE MOST UP-TO-DATE MEDICAL EQUIPMENT. IT WOULD BE OF GREAT VALUE IF I COULD BE INFORMED IF THIS WAS SAFE. THANK YOU. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2547820 ALARIS SYSTEMS ASENA GH SYRINGE DRIVER PUMP, INFUSION FRN CAREFUSION 2200, INC. ASENA GH

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Female Life Threatening| O| D ALFENTANIL | MIDAZOLAM| SODIUM CHLORIDE 0.9%