BEUDAMED
    FDA Adverse Event Other Summary report: N

    ALARIS SYSTEM SYRINGE PUMP MODULE

    MDR report key: 1112186 · Received August 6, 2008

    Report

    Report Number
    2016493-2008-00116
    Event Type
    Other
    Date Received
    August 6, 2008
    Date of Event
    July 14, 2008
    Report Date
    July 16, 2008
    Manufacturer
    CARDINAL HEALTH ALARIS PRODUCTS
    Product Code
    FRN
    PMA / PMN Number
    K023264
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT INFORMATION REQUESTED AND ALL AVAILABLE INFORMATION IS INCLUDED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED AN OVERINFUSION OF REMIFENTANIL. REPORTS THAT THE ANESTHESIOLOGIST USER SETS UP ALL INFUSIONS PRIOR TO CONNECTING TO THE PATIENT. BETWEEN 7:00 AM - 8: AM, USER SET UP AN INFUSION USING GUARDRAILS, OF REMIFENTANIL 0.1 MCG/KG, RATE 3.6 ML./HR WITH A SYRINGE VOLUME OF 40 ML. THE INFUSION WAS CONNECTED TO THE PATIENT AT 8:00 AM. AT 9:00 AM, THE USER NOTED THE SYRINGE WAS ALMOST EMPTY AND 36 ML HAD INFUSED. NO PATIENT HARM REPORTED, NO MEDICAL INTERVENTION REQUIRED AND NO ILL EFFECTS EXPERIENCED BY THE PATIENT. THE DATA SET AND EVENT LOGS FROM THE PCU AND SYRINGE MODULE WERE RECEIVED. INVESTIGATION IS ON-GOING. A FOLLOW UP REPORT WILL BE FILED UPON COMPLETION OF THE INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALARIS SYSTEM SYRINGE PUMP MODULE FRN, PUMP, INFUSION FRN CARDINAL HEALTH ALARIS PRODUCTS 8110 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other ALARIS PC UNIT