BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALARIS SYSTEM PCA MODULE

    MDR report key: 1092146 · Received August 1, 2008

    Report

    Report Number
    2016493-2008-00082
    Event Type
    Injury
    Date Received
    August 1, 2008
    Date of Event
    July 5, 2008
    Report Date
    July 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
    CA
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURER'S REPORT DATE: 7/30/2008. INFO HAS BEEN PROVIDED TO THE CUSTOMER ON THE PURPOSE OF THE CUSTOM CONCENTRATION FUNCTION AND THE APPLICABILITY OF THIS FUNCTION TO VARIOUS PT POPULATIONS. ADDITIONALLY, INFO WAS PROVIDED WITH REFERENCE TO ADDING HARD GUARDRAILS LIMITS IF THE CUSTOM CONCENTRATION FEATURE WILL BE CONTINUED TO BE USED. THE CUSTOMER REPORTS THAT THEY HAVE ALREADY TAKEN STEPS TO PREVENT THE RECURRENCE OF DOSING ERRORS WITH THE CUSTOM CONCENTRATION FEATURE BY ADDING HARD LIMITS FOR MINIMUM CONCENTRATIONS IN THEIR DATASET FOR PCA DRUGS, CHANGING THE AVAILABLE CONCENTRATIONS IN THEIR DATASET TO MATCH THE CONCENTRATIONS IN THEIR STANDARD PHYSICIAN ORDERS, AND CHANGING THEIR CPOE ORDER SETS TO MATCH THEIR STANDARD PCA ORDERS. PT INFO REQUESTED AND ALL AVAILABLE INFO IS INCLUDED IN SECTION A AND B. THIS REPORT WAS FILED BY THE MANUFACTURER.

    Description of Event or Problem · 1

    A FEMALE BEING EVALUATED FOR ABDOMINAL AND HIP PAIN, GETTING PCA, WAS FOUND TO HAVE DEPRESSED RESPIRATORY RATE, O2 SATS IN THE 80'S, AND VITAL SIGN CHANGES; WAS GIVEN NARCAN AND FULLY RECOVERED WITH NO PERMANENT SEQUELAE. OTHER WAS FOR HYDROMORPHONE 10 MG/49 ML, PCA ONLY/NO CONTINUOUS, DOSE 200 MCG (1 ML), 6 MINUTE LOCKOUT, MAX LIMIT 3200 MCG/2 HOURS. AT APPROX. 2:15AM, A 60CC SYRINGE WITH APPROX 50ML VOLUME WAS PROGRAMMED. AT 3:30AM, THE NURSE CHECKED THE SYRINGE AND NOTICED THE SYRINGE WAS EMPTY. REVIEW OF THE DEVICE EVENT LOG SHOWED THAT THE PCA WAS INITIALLY ATTACHED TO THE SYSTEM IN 2008 AT APPROXIMATELY 2:11PM AND WAS PROGRAMMED TO INFUSE HYDROMORPHONE, WITH THE USER ENTERING A DRUG AMOUNT OF 200MCG AND A DILUENT VOLUME OF 49ML. THIS RESULTED IN A CONCENTRATION OF 4.08MCG/ML. THE OPERATOR THEN ENTERED THE PCA DOSE OF 200MCG, LOCKOUT 6 MINUTES AND MAX LIMIT OF 3200MCG / 2 HOURS. THE DEVICE INITIATED AN ALERT THAT THE PROGRAMMING WAS BELOW THE SOFT GUARDRAIL CONCENTRATION LIMIT OF 20MCG / ML; THE OPERATOR ELECTED NOT TO CONTINUE AND CHANGED THE DILUENT VOLUME TO 50ML, WHICH STILL RESULTED IN A PROGRAMMED CONCENTRATION OF ONLY 4MCG / ML. THE DEVICE AGAIN INITIATED AN ALERT THAT THE CONCENTRATION WAS BELOW THE GUARDRAIL LIMIT OF 20MCG / ML, AND THIS TIME THE OPERATOR ELECTED TO PROCEED. UPON THE FIRST PCA REQUEST ON THE SAME DAY AT 2:22PM, THE DEVICE INFUSED APPROXIMATELY 48.679ML. A SECOND PCA REQUEST WAS INITIATED, THE DEVICE ALERTED A NEAR END ALARM, THE USER THEN REPROGRAMMED THE DEVICE USING THE GUARDRAILS CONCENTRATION OF 200MCG/1ML. THIS CHANGE RESULTED IN ALL REMAINING PCA INFUSION REQUESTS INFUSING A VOLUME OF 1ML LEADING UP TO THE REPORTED TIME OF OVERINFUSION EVENT. ON TWO DAYS LATER, AT APPROXIMATELY 2:11AM, THE SYRINGE WAS REPLACED AND THE USER PROGRAMMED THE DEVICE BY AGAIN SELECTING THE CUSTOM CONCENTRATION OPTION INSTEAD OF THE AVAILABLE STANDARD CONCENTRATION OF 200 MCG/1 ML. THE DRUG AMOUNT OF 200MCG AND THE DILUENT VOLUME OF 49ML WERE ENTERED RESULTING IN A CONCENTRATION OF 4.08MCG / ML. THE OPERATOR MAINTAINED THE REMAINING PROGRAMMING OF PCA DOSE 200MCG, LOCKOUT 6 MINUTES AND MAX LIMIT OF 3200MCG / 2 HOUR. THE DEVICE INITIATED AN ALERT THAT THE CONCENTRATION WAS BELOW THE GUARDRAIL LIMIT OF 20MCG / ML, FOLLOWING WHICH THE OPERATOR ELECTED TO PROCEED. A PCA REQUEST WAS MADE AND AGAIN THE DEVICE INFUSED APPROXIMATELY 49.0003ML. NO OTHER PCA INFUSIONS WERE PERFORMED FOLLOWING THE REPORTED OVERINFUSION EVENT WITH THIS DEVICE. THE TWO IDENTIFIED EVENTS WHERE OVERINFUSIONS OCCURRED APPEAR TO BE FROM PROGRAMMING ERRORS WITH RESPECT TO THE ORDER AS PROVIDED BY THE CUSTOMER. BOTH EVENTS ARE THE RESULT OF USING THE CUSTOM CONCENTRATION APPLICATION INSTEAD OF USING THE AVAILABLE STANDARD CONCENTRATION OF 200 MCG/1 ML. IN BOTH EVENTS, THE USER ENTERED THE CONCENTRATION AS 200MCG PER 49 OR 50 ML SYRINGE VOLUME WHEN IT SHOULD HAVE BEEN ENTERED AS 200MCG /1ML.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR Life Threatening| R ALARIS PC UNIT