BEUDAMED
    FDA Adverse Event Death Summary report: N

    MS16A SYRINGE DRIVER

    MDR report key: 378152 · Received February 21, 2002

    Report

    Report Number
    9612511-2002-00001
    Event Type
    Death
    Date Received
    February 21, 2002
    Report Date
    February 14, 2002
    Manufacturer
    GRASEBY MEDICAL LTD.
    Product Code
    FRN
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    MS16A SYRINGE DRIVERS IN USE AT TIME OF PT DEATH AT HOSP. DEVICE (BELIEVED TO BE IN USE AT THE TIME OF THE INCIDENT). ANOTHER DEVICE (SUSPECTED TO HAVE BEEN IN USE AT THE TIME OF THE INCIDENT). THE PUMP REPORTEDLY SET TO INFUSE AT A RATE OF 2MM/H AT THE TIME OF THE INCIDENT. THE PUMP WAS BEING USED ON A PT WHO DIED UNEXPECTEDLY SECOND DAY POST OP. IT WAS BEING USED TO ADMINISTER ANTI-COAGULATION THERAPY. THE PUMP HAS BEEN REPORTED AS NOT DELIVERING THE DOSE TO THE CORRECT TIME. STAFF WERE UNSURE WHICH OF THE ABOVE PUMPS WERE IN USE. BOTH HAVE BEEN SECURED AND INVESTIGATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MS16A SYRINGE DRIVER SYRINGE DRIVER FRN GRASEBY MEDICAL LTD. MS16A - NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Death