BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MS26 SYRINGE DRIVER

    MDR report key: 730363 · Received June 22, 2006

    Report

    Report Number
    9612511-2006-00030
    Event Type
    Malfunction
    Date Received
    June 22, 2006
    Report Date
    June 22, 2006
    Manufacturer
    SMITHS MEDICAL INTERNATIONAL LTD. (PREVIOUSLY GRASEBY MEDICAL LTD.)
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURER COMPLETED THE ENTIRE FORM. H3: RETURN OF DEVICE TO MANUFACTURER FOR EVALUATION ANTICIPATED. FOLLOW UP MDR WILL BE SUMBITTED.

    Description of Event or Problem · 1

    OUR REF: 2006 06204/1-MHRA REF: 2006/006/008/291/002 - ALLEGED UNDERINFUSION. PATIENT'S SPOUSE CALLED STAFF AS PT STRUGGLING WITH BREATHING WAS COUGHING AND RESTLESS. SYRINGE DRIVER AND PUMP CHARTS CHECKED AND FOUND THAT THE PT HAD NOT HAD ANY MIDAZOLAM SINCE LUNCH AS THE DRIVER WASN'T WORKING. NURSE IN CHARGE OF CARE WAS ASKED IF SHE KNEW HOW TO CHECK THE DRIVER AND DOCUMENT IT AND SHE CONFIRMED THAT SHE DID. NO DETAILS OF PUMP SETTINGS OR WHETHER AN ALARM WAS ACTIVATED. PT GIVEN DOSE OF MIDAZOLAM AS PER PRESCRIPTION AND SALINE NEBULISER GIVEN. NO REPORTS OF INJURY.

    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 UNKNOWN