BEUDAMED
    FDA Adverse Event Death Summary report: N

    ALARIS SYSTEM PUMP MODULE

    MDR report key: 1081407 · Received July 25, 2008

    Report

    Report Number
    2016493-2008-00103
    Event Type
    Death
    Date Received
    July 25, 2008
    Date of Event
    June 22, 2008
    Report Date
    June 26, 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
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    CUSTOMER REPORTED AN OVERINFUSION OF ATIVAN. CUSTOMER KNOWS LIMITED EVENT DETAILS. ATIVAN 2 ML OVER 1 MINUTE WAS ORDERED FOR PT COMFORT MEASURES. THE PUMP ALARMED MULTIPLE TIMES, THE USER COULD NOT RECALL THE ALARM MESSAGES AND SEVERAL UNK KEY PRESSES WERE PERFORMED RESULTING IN THE ENTIRE 40 MG BAG OF ATIVAN, VOLUME UNK, TO INFUSE. REPORTS NO MEDICAL INTERVENTION INITIATED TO TREAT THE OVERINFUSION. THE PT DIED 1 HR AFTER THE EVENT. THE CUSTOMER REPORTS THAT THE PT'S DEMISE WAS EXPECTED BUT THAT THE ADDITIONAL MEDICATION MAY HAVE HASTENED THE PT'S DEATH. PCU AND LVP DEVICES AND LOGS REQUESTED. BECAUSE THE DEVICES WERE NOT SEQUESTERED OR SERIAL NUMBERS NOTED AT THE TIME OF THE EVENT, NO DEVICES OR LOGS ARE AVAILABLE FOR EVAL. THE CUSTOMER IS ATTEMPTING TO LOCATE THE DEVICES. IF THE DEVICES OR LOGS ARE LOCATED, 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 PRODUCTS 8100 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Death ALARIS PC UNIT