BEUDAMED
    FDA Adverse Event Other Summary report: N

    ALARIS SYSTEM PUMP MODULE

    MDR report key: 1031757 · Received April 18, 2008

    Report

    Report Number
    2016493-2008-00018
    Event Type
    Other
    Date Received
    April 18, 2008
    Date of Event
    March 19, 2008
    Manufacturer
    CARDINAL HEALTH ALARIS PRODUCTS
    Product Code
    FRN
    PMA / PMN Number
    K950419
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    INFUSION WAS STARTED AROUND 2 AM ON 3/19; AT 4 AM RN FOUND BAG EMPTY. INFUSION WAS HYDROMORPHONE, 1 MG/ML IN A 100ML BAG. THE ENTIRE BAG INFUSED IN 2 HOURS, NOT THE 12 HOURS IT WAS INTENDED TO RUN AS IT WAS SUPPOSED TO BE PROGRAMMED AT 8ML/HR. PT WAS OPIATE TOLERANT ON LARGE DOSES OF MULTIPLE NARCOTICS, AND THERE WAS NO EFFECT ON THE PATIENT; NO NARCOTIC REVERSAL AGENT WAS ADMINISTERED. BAG WAS IN A "CLAMSHELL" TYPE OF SECURITY DEVICE THAT WOULD NOT NECESSARILY PREVENT DIVERSION BUT IS DESIGNED TO MAKE IT DIFFICULT TO GET TO THE VOLUME; CUSTOMER RULED OUT POSSIBILITY OF DIVERSION. EVENT LOGS FROM THE PCU WERE REVIEWED BY CARDINAL. THERE WERE THREE LVPS ATTACHED TO THE PCU AT THE TIME OF THE EVENT. ONE WAS INFUSING AT A RATE OF 100 ML/HR, ONE WAS INFUSING A PRIMARY AT A RATE OF 40 ML/HR. TWO HOURS BEFORE THE TIME IN QUESTION A RATE OF 8 ML/HR AND A VTBI OF 100 ML WERE PROGRAMMED INTO THE THIRD PUMP, AND 2 HOURS LATER THIS PUMP WAS SELECTED, THE SECONDARY INFUSION OPTION WAS ACTIVATED, THE SECONDARY INFUSION RATE WAS SELECTED AS 100 ML /HR AND THE VTBI AT 102 ML. IT IS BELIEVED THAT A SECONDARY INFUSION PROGRAM MEANT FOR THE SECOND PUMP WAS PROGRAMMED INTO THE THIRD PUMP; BASED ON THIS LOG REVIEW THE CAUSE FOR THE REPORTED OVER INFUSION IS BELIEVED TO BE USER PROGRAMMING ERROR.

    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 Other ALARIS SYSTEM PC UNIT (B) (4)| ALARIS SYSTEM PUMP MODULES (B) (4) & (B) (4)