BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MS16A SYRINGE DRIVER

    MDR report key: 509907 · Received February 2, 2004

    Report

    Report Number
    9612511-2004-00002
    Event Type
    Injury
    Date Received
    February 2, 2004
    Date of Event
    January 30, 2003
    Report Date
    January 30, 2004
    Manufacturer
    GRASEBY MEDICAL LTD.
    Product Code
    FRN
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PT BEING TREATED AT HOME FOR PAIN/SYMPTOM CONTROL ASSOCIATED WITH ADVANCED METASTATIC DISEASE. DEVICE INFUSING HYDROMORPHONE 50 MGMS, BUSCOPAN 60 MGMS AND HALOPERIDOL 3 MG AT A RATE OF 02 MM/HR FOR 24 HOUR DELIVERY. PT ACCIDENTALLY DROPPED THE PUMP INTO A SINK OF WATER. PT'S SPOUSE CONTACTED NURSE AFTER PUMP HAD FALLEN INTO WATER. SPOUSE EXPRESSED CONCERN THAT THE PUMP WAS NOT WORKING PROPERLY AND STATED THAT SPOUSE HAD OBSERVED AN UNUSUAL NOISE FROM THE PUMP. NURSE NOTED THAT THE SYRINGE REMAINED SECURED TO THE PUMP AFTER THE ACCIDENT. PT HAD DECREASED RESPIRATORY RATE AND DROWSINESS. NO MEDICAL INTERVENTION REQUIRED BUT THE PT WAS ADMITTED BACK INTO THE HOSPICE FOR SUPERVISION AND MONITORING FOR ANY POTENTIAL COMPLICATIONS.

    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 31 YR Hospitalization