BEUDAMED
    FDA Adverse Event Death Summary report: N

    NON-VENTED DUAL CHAN. PLUMSET

    MDR report key: 665337 · Received January 17, 2006

    Report

    Report Number
    9615050-2006-00206
    Event Type
    Death
    Date Received
    January 17, 2006
    Date of Event
    December 22, 2005
    Report Date
    December 23, 2005
    Manufacturer
    HOSPIRA HOLDINGS DE COSTA RICA LTD.
    Product Code
    FPA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER CONTACT REPORTED A TUBING SEPARATION. THE PT WAS RECEIVING 250ML OF NORADRENALINE (1MG/1ML) AT A RATE OF 40ML/HR. AT AN UNSPECIFIED ITME, THE CLINICIAN ORDERED THAT THE INFUSION RATE BE INCREASED BECAUSE THE PT'S BLOOD PRESSURE CONTINUED TO BE "LOW." THE INFUSION RATE CONTINUED TO BE INCREASED UNTIL THE NORADRENALINE WAS BEING DELIVERED AT A RATE OF 120ML/HR. THE RN NOTED AT THIS TIME THAT THE MALE LUER HAD BECOME SEPARATED FROM THE TUBING SET AND THE MEDICATION WAS NOT REACHING THE PT. AT THIS TIME, THE CLINICIAN WAS NOTIFIED AND THE PT WAS TREATED WITH A 2ML, BOLUS DOSE OF NORADRENALINE. THERAPY WAS RESUMED USING A REPLACEMENT TUBING SET. THE PT EXPIRED AT AN UNSPECIFIED TIME "SOME HOURS" AFTER THE REPORTED EVENT. THE REPORTER STATED THAT IT IS UNCLEAR AT THIS TIME IF THE PT'S DEATH WAS THE RESULT OF THE REPORTED EVENT. THOUGH REQUESTED, NO ADDITIONAL INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NON-VENTED DUAL CHAN. PLUMSET ADMINISTRATION SET FPA HOSPIRA HOLDINGS DE COSTA RICA LTD. NA 320035H

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Death