BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALARIS SYSTEM PUMP MODULE

    MDR report key: 1138495 · Received August 27, 2008

    Report

    Report Number
    2016493-2008-00121
    Event Type
    Injury
    Date Received
    August 27, 2008
    Date of Event
    August 4, 2008
    Report Date
    August 4, 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
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    PT INFO REQUESTED AND ALL AVAILABLE INFO IS INCLUDED.

    Description of Event or Problem · 1

    CUSTOMER CALLED REQUESTING LOG ANALYSIS FOR REPORT OF HEPARIN OVERINFUSION: INFUSION WAS SUPPOSED TO BE AT 0.3 ML/HR, NURSE THOUGHT SHE MAY HAVE INADVERTENTLY ENTERED 0.5 ML/HR, BUT CUSTOMER SAYS LOG SHOWS 5 ML/HR WAS PROGRAMMED AND WANTED VERIFICATION OF THIS. INFUSION WAS REPORTED TO HAVE RUN FROM 7 PM UNTIL MIDNIGHT ON THE DAY IN QUESTION. REPORTED THAT THERE WAS A CLINICAL IMPACT WITH PROTAMINE GIVEN, BUT PT WAS SUBSEQUENTLY FINE. THE DEVICE LOG WAS REVIEWED FOR THE TIME PERIOD IN QUESTION. THE LOG SHOWS THAT HEPARIN 100 UNITS/ML WAS SELECTED FROM THE DRUG LIBRARY, USING THE PICU PROFILE. AFTER SELECTING THE DRUG THE USER RECEIVED A CLINICAL ADVISORY TO VERIFY CORRECT STANDARD CONCENTRATION ON PUMP TO BAG LABEL PRIOR TO PROGRAMMING. THE USER CONFIRMED THE ADVISORY AND PROGRAMMED THE INFUSION FOR A RATE OF 0.3 ML/HR, VTBI OF 50 ML, AND DOSE OF 10 UNITS/LG/HR (PT WEIGHT WAS RECORDED AS 3 KG). BEFORE STARTING THE INFUSION THE USER SELECTED THE DELAY START OPTION AND ENTERED A DELAY PERIOD OF 15 MINUTES. AFTER FIFTEEN SECONDS OF DELAY, THE MODULE WAS ACCESSED AND THE RATE WAS CHANGED TO 5ML/HR (166.7 UNITS/KG/H) AND THE USER ELECTED TO IMMEDIATELY START THE INFUSION. BEFORE THE INFUSION STARTED, THE GUARDRAIL WARNING APPEARED THAT THE DOSE EXCEEDS THE GUARDRAILS LIMITS OF 50 UNIT/KG/H (CUSTOMER'S DATASET WAS REVIEWED, AND IT WAS DETERMINED THAT THE HEPARIN 100 UNITS/ML DRUG SELECTION HAS NO HARD LIMIT IN THE PICU PROFILE. THE SOFT LIMIT IS SET TO 50 UNITS/KG/H). THE USER ELECTED TO PROCEED AND THE INFUSION STARTED AT 18:05. AT 00:16, AFTER DELIVERING APPROX 30.9 MLS, THE MODULE WAS ACCESSED AND THE INFUSION WAS PAUSED. THE USER THEN ENTERED INTO THE SETUP OPTION FOR THE MODULE AND CHANGED THE DRUG AMOUNT TO 25000 UNITS AND THE DILUENT TO 250 MLS WHICH HAD NO EFFECT ON THE ORIGINAL CONCENTRATION SINCE BOTH WERE 100:1. THE USER THEN CHANGED THE DOSE AMOUNT TO 10 UNITS/KG/H. THIS CAUSED THE RATE TO BE RECALCULATED AT 0.3 ML/HR. THE USER THEN RESTARTED THE INFUSION. EIGHT MINS LATER, THE MODULE WAS ACCESSED AND TURNED OFF, TERMINATING THE INFUSION. THE LOG INDICATES THAT DURING THE APPROX 6 HOURS THAT THE INFUSION RAN, APPROX 30 MLS OF FLUID WAS DELIVERED. THE ROOT CAUSE OF THE CUSTOMER'S EXPERIENCE WAS DETERMINED TO BE USER PROGRAMMING. REQUESTED FROM CUSTOMER THE RESULTS OF THEIR INTERNAL INVESTIGATION IF THEY DETERMINE WHY THE PROGRAMMING OCCURRED THE WAY IT DID. TO DATE HAVE NOT RECEIVED THIS INFO.

    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 Required Intervention ALARIS SYSTEM PC UNIT