BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALARIS PUMP MODULE ADMINISTRATION SET

    MDR report key: 6632153 · Received June 9, 2017

    Report

    Report Number
    9616066-2017-00887
    Event Type
    Injury
    Date Received
    June 9, 2017
    Date of Event
    May 22, 2017
    Report Date
    May 22, 2017
    Manufacturer
    CAREFUSION
    Product Code
    FPA
    PMA / PMN Number
    K944320
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: 1000ML BAXTER BAG, NDC 0338-0049-04, LOT NUMBER Y232694, EXP OCT 18, 0.9% SODIUM CHLORIDE INJECTION; 100ML BAXTER BAG, NDC 0338-0709-48, LOT NUMBER P357624, EXP DEC 17, POTASSIUM CHLORIDE; NON-BD SEC TUBING, PRI TUBING. THE CUSTOMER¿S REPORT OF A POTASSIUM OVERINFUSION WAS NOT CONFIRMED FROM THE EVENT LOG HOWEVER A CHECK VALVE FAILURE WAS CONFIRMED IN THE PRIMARY SET. ANALYSIS OF THE PCU EVENT LOG SHOWS THAT AT 8:52 AM ON (B)(6) 2017 A BASIC INFUSION WAS PROGRAMMED TO RUN AT 5ML/HR. A BASIC SECONDARY INFUSION WAS THEN PROGRAMMED TO RUN AT 100ML/HR WITH A VTBI OF 200ML. AT 9:09 AM, THE INFUSION WAS PAUSED AND SWITCHED FROM SECONDARY TO PRIMARY MODE. THE PRIMARY RATE WAS CHANGED TO 100ML/HR AND THE INFUSION WAS STARTED. AT 9:18 AM, THE DEVICE WAS CHANNELED OFF AND THE SYSTEM WAS SHUT DOWN AND POWERED OFF. THE VOLUME RECORDED AS BEING INFUSED DURING THIS PERIOD WAS 13.711ML FOR THE PRIMARY INFUSION AND 28.011ML FOR THE SECONDARY INFUSION. FUNCTIONAL TESTING FOUND THE DEVICE TO BE DELIVERING FLUID WITHIN SPECIFICATION. FUNCTIONAL TESTING OF THE PRIMARY SET RESULTED IN BACKFLOW FROM THE SECONDARY BAG INTO THE PRIMARY BAG INDICATING A FAULTY CHECK VALVE, HOWEVER THE CHECK VALVE PASSED SUPPLIER TESTING AND NO PARTICULATES WERE FOUND ON THE MEMBRANE. THE CAUSE OF THE REPORTED EVENT WAS IDENTIFIED AS A BACKFLOW ISSUE DUE TO A FAULTY CHECK VALVE. THE CAUSE OF THE CHECK VALVE FAILURE IS UNKNOWN.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE SECONDARY INFUSION OF 100ML OF POTASSIUM WAS PROGRAMMED TO INFUSE AT 100ML/HR WITH 1000ML NS INFUSING AS A PRIMARY AT 5ML/HR. THE POTASSIUM WAS BACK FLUSHED WITH AN ADDITIONAL 80-100ML OF NS FROM THE PRIMARY BAG TO DILUTE THE POTASSIUM FURTHER. THE POTASSIUM BAG EMPTIED IN ABOUT 10 - 15 MINUTES. THE PATIENT COMPLAINED OF A BURNING SENSATION AT THE PERIPHERAL IV SITE AND THE IV LINE WAS FLUSHED WITH NS TO RELIEVE THE BURNING SENSATION. THE PATIENT WAS MONITORED FOR CARDIAC ISSUES, PAIN RELIEF AND ANY NEW SYMPTOMS, AND THERE WAS NO LASTING PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    411561 ALARIS PUMP MODULE ADMINISTRATION SET SET, ADMINISTRATION, INTRAVASCULAR FPA CAREFUSION 2420-0007

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention