BEUDAMED
    FDA Adverse Event Death Summary report: N

    GAMBRO DIALYSIS MACHINE

    MDR report key: 283920 · Received June 30, 2000

    Report

    Report Number
    283920
    Event Type
    Death
    Date Received
    June 30, 2000
    Date of Event
    May 29, 2000
    Report Date
    June 30, 2000
    Manufacturer
    GAMBRO
    Product Code
    FII
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    AT 1500 FENTANYL PUMP FOR SHIFT WITH AMOUNT INFUSED AS 54CC (PUMP RATE 8CC/HR). AT 1730 PT STABLE, DIALYSIS CONTINUIM. AT 1748 PT WITH ANGINAL RESPIRATIONS, BRADYCARDIC AND NO BLOOD PRESSURE. DISCARDED FROM DIALYSIS MACHINE AND MEDICATION PUMPS. PT PRONOUNCED AT 1804, AT END OF THE EVENT, NOTED THAT FENTANYL BAG WAS EMPTY AND DISCONNECTED FROM PUMP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GAMBRO DIALYSIS MACHINE DIALYSIS FII GAMBRO 333103001 *

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Death 8ML/HR (31.15HR).| IV FENTANYL NACL 0.9% 2500MCG/250ML,