BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALARIS PUMP MODULE

    MDR report key: 6925848 · Received October 6, 2017

    Report

    Report Number
    2016493-2017-00588
    Event Type
    Injury
    Date Received
    October 6, 2017
    Date of Event
    September 10, 2017
    Report Date
    September 11, 2017
    Manufacturer
    CAREFUSION
    Product Code
    FRN
    PMA / PMN Number
    K950419
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: 500 ML BAXTER BAG, LOT # Y233288, EXP. AUG 18, 10% DEXTROSE INJECTION USP. THE CUSTOMER¿S REPORT OF AN OVERINFUSION WAS NOT CONFIRMED. ANALYSIS OF THE EVENT LOG SHOWS THAT AT 7:40 AM ON (B)(6) 2017 THE PUMP MODULE WAS PROGRAMMED TO INFUSE IV FLUID AT A RATE OF 9.4ML/HR WITH A VTBI OF 9.4ML. THE INFUSION CONTINUED UNTIL 12:45 PM AND RECORDED 35.725ML AS BEING INFUSED. THE 500ML FLUID CONTAINER WAS RECEIVED WITH APPROXIMATELY 120ML REMAINING, HOWEVER THE STARTING VOLUME CANNOT BE VERIFIED. FUNCTIONAL TESTING WAS PERFORMED AND THE DEVICE WAS DELIVERING FLUID WITHIN SPECIFICATION. NO ANOMALIES OR LEAKING WERE OBSERVED WITH THE PRIMARY SET. THE ROOT CAUSE OF THE REPORTED OVERINFUSION WAS NOT IDENTIFIED.

    Additional Manufacturer Narrative · 1

    THE EVENT LOGS HAVE BEEN RECEIVED AND THE EVALUATION IS PENDING. A FOLLOW UP REPORT WILL BE SUBMITTED WITH INVESTIGATION RESULTS ONCE THE EVALUATION HAS BEEN COMPLETED. NO DEVICES RECEIVED, LOG REVIEW ONLY.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT AN IV BAG (500 ML) WAS INITIATED ON (B)(6) 2017 AT 0740 WITH A RATE OF 9.5ML/HR USING THE "SCN GUARDRAILS SET" AND INFUSED FASTER THAN EXPECTED. THE TOTAL VOLUME INFUSED ACCORDING TO THE SCREEN WAS 35.31 ML, HOWEVER THE USER ESTIMATED ONLY 100 ML REMAINED IN THE IV BAG. THE USER STOPPED THE INFUSION, THE MD WAS NOTIFIED AND UNSPECIFIED NEW ORDERS WERE INITIATED. THE NOTED CLINICAL EFFECT OF THE EVENT WAS ¿SIGNIFICANT URINE OUTPUT¿ AND THE PATIENT REMAINED STABLE AND ACTIVE. AFTER THE EVENT, THE UNIT MANAGER PERFORMED INITIAL TESTING OF THE EVENT DEVICES AND NOTED THE DRIP FACTOR FLUCTUATED WITH THE SAME SETTINGS; FURTHER EVALUATION WAS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    701119 ALARIS PUMP MODULE PUMP, INFUSION FRN CAREFUSION 8100

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention