BEUDAMED
    FDA Adverse Event Death Summary report: N

    ALARIS PUMP MODULE

    MDR report key: 3883988 · Received June 11, 2014

    Report

    Report Number
    2016493-2014-00283
    Event Type
    Death
    Date Received
    June 11, 2014
    Date of Event
    May 8, 2014
    Report Date
    May 15, 2014
    Manufacturer
    CAREFUSION CORP
    Product Code
    FRN
    PMA / PMN Number
    K950419
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). NO DEVICE RECEIVED, LOG REVIEW ONLY. THE CUSTOMER'S REPORT OF AN UNDERINFUSION OF MORPHINE WAS CONFIRMED. THE PCU EVENT LOG SHOWS THAT MORPHINE STANDARD CONCENTRATION 50MG/250ML WAS PROGRAMMED AT 3:31 PM ON (B)(6) 2014. THE USER ENTERED A CONCENTRATION OF 0.2MG/ML AND A DOSE OF 2MG/HR (LEADING TO A RATE OF 10ML/HR). BETWEEN 4:00 PM AND 8:11 PM, THE DOSE WAS CHANGED 4 TIMES (WITH RATES OF 25ML/HR, 35ML/HR AND 55 ML/HR). THE INFUSION RAN AT 55 ML/HR UNTIL 7:57 AM ON (B)(6) 2014. AT 7:58 AM ON (B)(6) 2014, THE PUMP MODULE WAS CHANNELED OFF AND SELECTED A FEW SECONDS LATER. THE USER THEN PROGRAMMED A CUSTOM CONCENTRATION INFUSION OF CONCENTRATED MORPHINE. THE USER ENTERED 100 MG FOR THE DRUG AMOUNT, 90 ML FOR THE DILUENT VOLUME AND 11 MG/HR FOR THE DOSE (LEADING TO A RATE OF 9.9 ML/HR). BETWEEN 10:04 AM AND 12:38 PM, THE DOSE WAS CHANGED 3 TIMES (LEADING TO RATES OF 10.8 ML/HR, 13.5 ML/HR AND 22.5 ML/HR). AT 7:17 PM, THE USER CHANGED THE DILUENT VOLUME TO 100ML (CONCENTRATION OF 1 MG/ML). THE USER CHANGED THE DOSE TO 25 MG/HR (LEADING TO A RATE OF 25 ML/HR). THESE ARE THE PARAMETERS THAT WERE PROVIDED BY THE CUSTOMER AS BEING PROGRAMMED AT 6:00 AM ON (B)(6) 2014. AT 10:27 AM ON (B)(6) 2014, THE USER CHANGED THE DILUENT VOLUME TO 50ML AND DOSE TO 25 MG/HR (LEADING TO A CONCENTRATION OF 2 MG/ML AND RATE OF 12.5 ML/HR). THE INFUSION RAN AT THIS RATE UNTIL 8:01 PM ON (B)(6) 2014 WHEN THE PUMP MODULE WAS CHANNELED OFF. AT 8:02 PM, THE USER PROGRAMMED A CUSTOM CONCENTRATION INFUSION OF CONCENTRATED MORPHINE. THE USER ENTERED 100 MG FOR THE DRUG AMOUNT, 100 ML FOR THE DILUENT VOLUME, AND 15 MG/HR FOR THE DOSE (LEADING TO A CONCENTRATION OF 1 MG/ML AND RATE OF 15 ML/HR). FIFTEEN MINUTES LATER AT 8:17 PM, THE USER CHANGED THE RATE TO 25 ML/HR. THE ROOT CAUSE OF THE CUSTOMER'S REPORT OF A MORPHINE UNDERINFUSION WAS IDENTIFIED AS A USER PROGRAMMING ISSUE. THE DILUENT VOLUME WAS DECREASED TO 50 ML AT 10:27 AM ON (B)(6) 2014. THE INFUSION RAN AT THE LOWER RATE OF 12.5ML/HR FOR APPROX 33.5 HOURS (10:27 AM ON (B)(6) 2014 TO 8:01 PM ON (B)(6) 2014).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT A PATIENT WAS STARTED ON COMFORT MEASURES ON (B)(6) 2014. SHE WAS STARTED ON A MORPHINE DRIP, 100 MG / 100 MLS AT 25ML/HR ON (B)(6) 2014 AT 0600. IT APPEARS PER THE EVENT LOG, THAT THE CONCENTRATION WAS CHANGED ON (B)(6) 2014 AT 10:24 AM WITH A NEW BAG CHANGE TO AN INCORRECT CONCENTRATION OF 100 MG / 50MLS AND CHANGED TO A RATE OF 12.5 ML/HR. THIS RAN UNTIL (B)(6) 2014 AT 8:25 PM WHEN THE ERROR WAS DISCOVERED. THE CONCENTRATION AND RATE WERE CORRECTED. THE PATIENT EXPIRED ON (B)(6) 2014. CUSTOMER STATES THAT THE PATIENT WAS EXPECTED TO EXPIRE AND THE EVENT DID NOT CAUSE OR CONTRIBUTE TO THE DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    344896 ALARIS PUMP MODULE INFUSION PUMP FRN CAREFUSION CORP 8100 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Death ALARIS PUMP MODULE TUBING: MODEL/LOT UNK| ALARIS PC UNIT, SN (B)(4)