BEUDAMED
    FDA Adverse Event Other Summary report: N

    ALARIS PCA MDULE

    MDR report key: 1193232 · Received October 6, 2008

    Report

    Report Number
    2016493-2008-00155
    Event Type
    Other
    Date Received
    October 6, 2008
    Date of Event
    August 7, 2008
    Report Date
    September 5, 2008
    Manufacturer
    CARDINAL HEALTH ALARIS PRODUCTS
    Product Code
    MEA
    PMA / PMN Number
    K032233
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT INFORMATION REQUESTED, AND ALL AVAILABLE INFORMATION IS INCLUDED.

    Description of Event or Problem · 1

    FACILITY BIOMED REPORTED 40-45 ML OF PCA MORPHINE INFUSED TOO RAPIDLY WITH NO ADVERSE EFFECTS TO THE PATIENT. FACILITY'S INTERNAL INVESTIGATION WITH ASSISTANCE OF 3RD PARTY DID NOT DETERMINE ROOT CAUSE. BIOMED STATES BETWEEN 1500 AND 1530, MORPHINE PRE-FILLED MONOJECT 55 MG/55 ML WAS PROGRAMMED FOR PCA ONLY DOSE 1.5 MG WITH LOCKOUT OF 10 MINUTES. INITIAL BOLUS OF 3 MG (3 ML) WAS GIVEN. BIOMED REVIEWED LOG AND THINKS 2 DOSES OF 1.5 ML INFUSED. AROUND 1620-1630 DEVICE ALARMED FOR "END OF SYRINGE." USER OPENED DEVICE TO VERIFY VOLUME LEFT IN SYRINGE, AND RESUMED INFUSION. THE ENTIRE SYRINGE INFUSED WITH NO HARM TO PATIENT. EVENT LOG REVIEWED SHOWS INITIAL PROGRAMMING FOR PCA WAS CORRECT : STANDARD CONCENTRATION OPTION MORPHINE 50 MG/50 ML, PCA DOSE ONLY MODE, DOSE 1.5 MG, LOCKOUT 10 MINUTES, MAX LIMIT 50 MG/4H (CONCENTRATION 1 MG/ML). BETWEEN 3:14 PM AND 4:20 PM, 3 PCA DOSES (1.5 ML EACH) AND A BOLUS DOSE OF 3 MG (3 ML) WERE DELIVERED. DURING SUBSEQUENT PROGRAMMING, THE USER CHOSE THE CUSTOM CONCENTRATION OPTION MORPHINE MG/ML, DRUG AMOUNT=1.5 MG, DILUENT AMOUNT=55 ML (CONCENTRATION 0.027 MG/ML). THE USER CONFIRMED THESE PARAMETERS AND THE RESTORED PARAMETERS OF PCA MODE, DOSE, LOCKOUT, MAX LIMIT, AND PRESSED THE START KEY. THIS RESULTED IN THE FOLLOWING MESSAGE DISPLAYED ON THE MAIN SCREEN: "THE VOLUME IN THE SYRINGE IS INADEQUATE TO DELIVER THE PROGRAMMED PCA DOSE. PRESS CONFIRM." THE CONFIRM SOFT KEY WAS PRESSED AND THE INFUSION STARTED. NOTE: WITH THE CONCENTRATION PROGRAMMED AS 1.5 MG/55ML, AND THE PCA DOSE SET AT 1.5 MG, ONE PCA DOSE WOULD BE 55 ML. AT 5:13 PM, A PCA DOSE WAS REQUESTED AND BECAUSE OF THE CONCENTRATION PROGRAMMED, THE ENTIRE CONTENT OF THE SYRINGE WAS DELIVERED. AT 5:32 PM, THE MODULE ALARMED SYRINGE EMPTY. AT 5:37 PM, THE MODULE WAS TURNED OFF. RE-EDUCATION OF STAFF WAS SUGGESTED AND OFFERED TO THE CUSTOMER CONCERNING PROPER PCA PROGRAMMING, AS WELL AS A SUGGESTION TO CONSIDER ELIMINATION OF THE CUSTOM CONCENTRATION OPTION AND/OR ADDING HARD LIMITS AROUND THE MINIMUM CONCENTRATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALARIS PCA MDULE MEA, PCA INFUSION PUMP MEA CARDINAL HEALTH ALARIS PRODUCTS 8120 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other LVP| PCU