BEUDAMED
    FDA Adverse Event Other Summary report: N

    ALARIS SYSTEM PUMP MODULE

    MDR report key: 1151527 · Received September 5, 2008

    Report

    Report Number
    2016493-2008-00140
    Event Type
    Other
    Date Received
    September 5, 2008
    Date of Event
    August 7, 2008
    Report Date
    August 8, 2008
    Manufacturer
    CARDINAL HEALTH ALARIS PRODUCT
    Product Code
    FRN
    PMA / PMN Number
    K012383
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL DEVICES INVOLVED: ALARIS INFUSION PUMP MODULE 8100, DEVICE MANUFACTURE DATE 03/2007. PATIENT INFORMATION REQUESTED, AND ALL AVAILABLE INFORMATION IS INCLUDED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED AN UNDERINFUSION OF TPN AND AN OVERINFUSION OF LIPIDS. PATIENT HAD TPN AND LIPIDS INFUSING ON 2 SEPARATE PUMP MODULES ATTACHED TO ONE PROGRAMMING MODULE. THE INTENDED INFUSION RATES WERE TPN AT 26 ML/HR AND LIPIDS AT 2 ML/HR. BOTH INFUSIONS WERE STARTED AT 1200 AM. AT 0430, THE CHANNEL WITH THE LIPIDS ALARMED FOR AIR-IN-LINE AND IT WAS NOTED THAT THE LIPIDS WERE INFUSING AT 26 ML/HR AND THE TPN AT 2 ML/HR. REPORTEDLY, THE PATIENT EXPERIENCED A HIGH BLOOD TRIGLYCERIDE LEVEL THAT RESOLVED SPONTANEOUSLY. NO BLOOD GLUCOSE ANOMALIES WERE REPORTED WITH THE TPN UNDERINFUSION. NO PATIENT HARM REPORTED, NO MEDICAL INTERVENTION REQUIRED AND NO LONG TERM ILL EFFECTS EXPERIENCED BY THE PATIENT. THE DATA SET AND EVENT LOGS FROM THE PCU AND LVP MODULES 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 PUMP MODULE FRN, INFUSION PUMP FRN CARDINAL HEALTH ALARIS PRODUCT 8100 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 15 MO Other ALARIS PC UNIT