BEUDAMED
    FDA Adverse Event Other Summary report: N

    ALARIS SYSTEM PUMP MODULE

    MDR report key: 1032473 · Received April 17, 2008

    Report

    Report Number
    2016493-2008-00031
    Event Type
    Other
    Date Received
    April 17, 2008
    Date of Event
    March 25, 2008
    Report Date
    March 25, 2008
    Manufacturer
    CARDINAL HEALTH ALARIS PRODUCTS
    Product Code
    FRN
    PMA / PMN Number
    K012383
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (4). (B) (4). THIS REPORT WAS FILED BY THE MFR.

    Description of Event or Problem · 1

    FACILITY REPORTED OVERINFUSION OF DOPAMINE WITH SUBSEQUENT DROP IN BP. DOPAMINE 400MG/250ML PROGRAMMED TO INFUSE AT 3 MCG/KG/MIN. TWICE WITHIN SEVERAL HOURS, BAG WAS FOUND EMPTY BEFORE EXPECTED, AND STAFF REPORTED VISUALIZING FREE FLOW IN SET AFTER SECOND EVENT. ONCE INFUSION WAS STOPPED AFTER EACH OVERINFUSION, BP DROPPED AND DOPAMINE WAS RESTARTED/RATE INCREASED. IN FIRST EVENT AT 4 AM, DOPAMINE HAD BEEN TITRATED OFF WITH TUBING LEFT IN DEVICE; DUE TO DROP IN BP, NURSE WENT TO ROOM TO RESTART INFUSION AND FOUND BAG EMPTY WHEN IT SHOULD HAVE HAD 170 ML LEFT. IN SECOND EVENT, NEW BAG WAS HUNG AT 6:45 AM AND BAG WAS FOUND EMPTY AT 9:30 AM. SCREEN SHOWED VI 63 ML, BUT 250 ML GONE FROM BAG. ANOTHER NEW BAG WAS THEN HUNG AND NURSE NOTED FREE FLOW IN TUBING WITH DEVICE DOOR CLOSED. SWITCHED INFUSION TO NEW DEVICE. BP DROPPED FROM 110S TO 70S SO DOPAMINE RATE INCREASED AND PATIENT QUICKLY STABILIZED WITH NO LONG TERM EFFECTS. FACILITY SENT IN TUBING SET AND INVESTIGATION IS ONGOING. FACILITY SENT IN WRONG LVP AND IS SEARCHING FOR CORRECT DEVICE TO SEND FOR EVAL. FOLLOW-UP REPORT WILL BE SENT WHEN INVESTIGATION IS COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALARIS SYSTEM PUMP MODULE FRN INFUSION PUMP FRN CARDINAL HEALTH ALARIS PRODUCTS 8100 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Other