BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MS26 SYRINGE DRIVER

    MDR report key: 728402 · Received June 15, 2006

    Report

    Report Number
    9612511-2006-00025
    Event Type
    Malfunction
    Date Received
    June 15, 2006
    Date of Event
    July 22, 2004
    Report Date
    June 13, 2006
    Manufacturer
    SMITHS MEDICAL INTERNATIONAL LTD. (PREVIOUSLY GRASEBY MEDICAL LTD.)
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AS A RESULT OF A FINDING DURING A RECENT INSPECTION, (FDA FORM FDA, FEI 3002088009) THE CO COMMITED TO REVIEW ALL COMPLAINTS FROM THE LAST 24 MONTHS TO IDENTIFY ANY THAT MIGHT BE CONSIDERED REPORTABLE WHICH HAVE NOT BEEN REPORTED. THAT REVIEW HAS BEEN COMPLETED AND THE FOLLOWING MEDWATCH FORMS REPRESENT ALL SUCH LATE REPORTS. H6: DEVICE EVAL=NO FAULTS FOUND WHICH WOULD CAUSE OR CONTRIBUTE TO ALLEGED INCIDENT.

    Description of Event or Problem · 1

    OUR REF: 2004 0827/1/1 - MHRA 2004/007/026/401/004. NO REPORTED PT INJURY OR MEDICAL INTERVENTION. ALLEGED INCIDENT = PT BEING TREATED FOR PAIN RELIEF FOR BRAIN METASTASIS AND LUNG CANCER. DEVICE SET UP TO INFUSE DIAMORPHINE 15MGS AND METOCLOPROMIDE 30MGS AT A RATE OF 53/24HRS. MEDICAL STAFF INCREASED DOSE. NURSE WENT TO CHANGE TO A LARGER DOSE AT 10-11AM THE FOLLOWING DAY AND NOTICED THAT THE SYRINGE DRIVER STARTED AT 18:25 HOURS THE PREVIOUS NIGHT AND RUN OUT TOO EARLY. HOSP COULD FIND NO FAULTS WITH DEVICE AND SENT IT TO SMITHS MEDICAL TO CONFIRM THEIR FINDINGS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR