BEUDAMED
    FDA Adverse Event Other Summary report: N

    MS26 SYRINGE DRIVER

    MDR report key: 496046 · Received November 6, 2003

    Report

    Report Number
    9612511-2003-00005
    Event Type
    Other
    Date Received
    November 6, 2003
    Date of Event
    July 3, 2003
    Report Date
    November 6, 2003
    Manufacturer
    GRASEBY MEDICAL LTD.
    Product Code
    FRN
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PT DEATH (PT BEING TREATED FOR TERMINAL CANCER OF THE THROAT). THE DEVICE WAS SET AROUND 10:30A.M. TO INFUSE DILAUDID AND VERSED (VOLUME, CONCENTRATION AND SYRINGE SIZE NOT KNOWN) AT A RATE OF 16MM PER 24 HOUR BY A NURSE AT THE HOME OF THE PT. AT APPROX MIDDAY, THE PT COMPLAINED TO THE SPOUSE OF NAUSEA AND DIZZINESS AND SLEPT THROUGHOUT THE AFTERNOON. AT AROUND 9PM THE NURSE RETURNED AND CONFIRMED THAT THE PT WAS COMATOSE AND A A DOCTOR WAS CALLED. THE RATE OF THE SYRINGE DRIVER WAS CHECKED AND FOUND TO BE SET AT A RATE OF 86MM PER 24 HOURS. THE PT WAS TRANSFERRED TO THE HOSP WHERE APPROPRIATE ANTIDOTES WERE ADMINISTERED. THE NEXT DAY THE PT WAS TRANSFERRED WHERE THEY DIED ONE WEEK LATER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MS26 SYRINGE DRIVER SYRINGE DRIVER FRN GRASEBY MEDICAL LTD. MS26 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Death| O