BEUDAMED
    FDA Adverse Event Death Summary report: N

    ALARIS PUMP MODULE

    MDR report key: 1923711 · Received December 8, 2010

    Report

    Report Number
    2016493-2010-00492
    Event Type
    Death
    Date Received
    December 8, 2010
    Date of Event
    October 5, 2010
    Report Date
    October 5, 2010
    Manufacturer
    CAREFUSION CORPORATION
    Product Code
    FRN
    PMA / PMN Number
    K012383
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SD, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PATIENT INFORMATION REQUESTED AND ALL AVAILABLE INFORMATION IS INCLUDED. THIS REPORT WAS FILED BY THE MANUFACTURER. THE EVENT LOGS WERE REVIEWED, SHOWING ON (B)(6) 2010, AT 10:38PM, THE USER PROGRAMMED AND STARTED THE INFUSION OF EPTIFIBATIDE, WITH A CONCENTRATION OF 200MG/100ML, PATIENT (B)(6) AND VTBI 50 ML. THE RATE WAS CALCULATED AS 2.487ML/H BASED ON THE DATASET INITIAL DEFAULT STARTING DOSE ENTRY OF 1MCG/KG/MIN. AT 11:14PM, THE INFUSION WAS PAUSED, THEN RESTARTED AT 11:23PM. AT 01:15AM, THE DEVICE BEGAN ALARMING FOR AIR IN LINE. THE USER OPENED THE DOOR GENERATING A FLOW STOP OPEN ALARM FOR SIX SECONDS, THEN CLOSED THE DOOR. THE USER PAUSED AND RESTARTED THE INFUSION SEVERAL MORE TIMES. AT 01:31AM, THE DEVICE ALARMED AGAIN FOR AIR IN LINE. TOTAL PRIMARY VI WAS LOGGED AS 6.188ML. THE USER THEN TURNED OFF THE DEVICE AT 01:38AM AND NO MORE INFUSIONS OCCURRED WITH THIS DEVICE. THE DEVICE WAS REQUESTED FOR FURTHER INVESTIGATION SEVERAL TIMES, BUT THE CUSTOMER HAS DECLINED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED AN OVERINFUSION OF INTEGRILIN (EPTIFIBATIDE). A 2 MG/ML CONCENTRATION IN 100 ML BAG WAS INTENDED TO INFUSE AT 1 MCG/KG/MIN. THE INFUSION WAS STARTED AT AROUND 10:30PM ON OCTOBER 4 AND THE BAG WAS FOUND EMPTY AT AROUND 1:40AM ON OCTOBER 5 WHEN THE PUMP ALARMED FOR AIR IN LINE, ALTHOUGH THE PUMP SHOWED ONLY HAVING DELIVERED 6 ML. THE PATIENT EXPERIENCED DECREASED HEMOGLOBIN AND PLATELETS AND SUBSEQUENTLY EXPIRED. THE INFUSION SYSTEM WAS SEQUESTERED, BUT THE TUBING SET WAS NOT SAVED. NO ADDITIONAL INFORMATION WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALARIS PUMP MODULE FRN CAREFUSION CORPORATION 8100 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 96 YR Death ALARIS PC UNIT, (B)(4)