BEUDAMED
    FDA Adverse Event Death Summary report: N

    GEM V/NV CKV 3 SS 20DP 20PK

    MDR report key: 443278 · Received February 14, 2003

    Report

    Report Number
    2016493-2003-00007
    Event Type
    Death
    Date Received
    February 14, 2003
    Date of Event
    January 16, 2003
    Report Date
    February 11, 2003
    Manufacturer
    ALARIS MEDICAL SYSTEMS, INC.
    Product Code
    FPA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    AN ALARIS SALES REPRESENTATIVE WAS INFORMED OF AN ALLEGED OVER INFUSION. ACCORDING TO THE REPORT, A PATIENT WITH THE HISTORY OF CHF WAS PLACED ON AN INFUSION OF UNKNOWN MEDICATION OR SOLUTION, ON GRAVITY IN THE ICU. A FREE FLOW INCIDENT WAS REPORTED, THAT WAS FELT TO HAVE CAUSED A FLUID OVERLOAD AND SUBSEQUENT DEATH PER THE HOSPITAL STAFF. UPON RECEIVING THIS INFORMATION COCO NTACTED THE NURSING DIRECTOR. SHE STATED "THE HOSPITAL IS AT 120% CAPACITY AND THEY ARE TREATING PATIENTS IN THE ICU WITHOUT PUMPS, WITH DISPOSABLE SETS AT GRAVITY". AFTER MULTIPLE ATTEMPTS, NO FURTHER INFORMATION WAS RECIEVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GEM V/NV CKV 3 SS 20DP 20PK DISPOSABLE INFUSION TUBING FPA ALARIS MEDICAL SYSTEMS, INC. 2426-0500 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Death