BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MS16A SYRINGE DRIVER

    MDR report key: 509969 · Received February 2, 2004

    Report

    Report Number
    9612511-2004-00003
    Event Type
    Injury
    Date Received
    February 2, 2004
    Date of Event
    June 21, 2003
    Report Date
    January 30, 2004
    Manufacturer
    GRASEBY MEDICAL LTD.
    Product Code
    FRN
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    INVOLVED IN CLINICAL INCIDENT WHERE UNIT IS BELIEVED TO HAVE OVER INFUSED. SYRINGE CHANGED IN DRIVER AT 1300 CHECKED BY STAFF NURSES - DRIVER CHECKED AT 1600 AND 7.5 ML HAD BEEN ADMINISTERED. PT SUFFERED RESPIRATORY DEPRESSION AND DECREASED LEVEL OF CONSCIOUSNESS. PT SEEN BY DOCTOR AND NALOXENE ADMINISTERED (ANTIDOTE TO NARCOTIC ANALGESICS) - NO FURTHER INFORMATION AVAILABLE. (HOSPITAL EBME TESTED DEVICE AND PUMP RAN WITHOUT CHANGING SETTINGS FOR 6 HOURS WITH CORRECT DISTANCE TRAVELLED I.E. NO FAULT FOUND).

    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 91 YR Hospitalization