BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS® PUMP MODULE

    MDR report key: 5336209 · Received December 30, 2015

    Report

    Report Number
    2016493-2015-00849
    Event Type
    Malfunction
    Date Received
    December 30, 2015
    Date of Event
    December 4, 2015
    Report Date
    December 10, 2015
    Manufacturer
    CAREFUSION SD
    Product Code
    FRN
    PMA / PMN Number
    K950419
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: 250ML BAXTER BAG, LOT # C990481, EXP. MAR 17, 5% DEXTROSE INJECTION USP; 100ML BAXTER BAG, LOT # P338293, EXP. AUG 16, POTASSIUM CHLORIDE; 500ML BAXTER BAG, LOT # C993048 / EXP. JAN 17, 5% DEXTROSE INJECTION USP; THERAPY DATE (B)(6) 2015. THE CUSTOMER¿S REPORT OF THE PUMP INFUSING TOO FAST WAS NOT CONFIRMED. THE PCU EVENT LOG SHOWED THE SOURCE PUMP MODULE WAS PROGRAMMED TO INFUSE IV FLUID AT 50ML/HR WITH A VTBI OF 450ML AT 10:24 AM ON (B)(6) 2015. THE INFUSION RAN UNTIL 12:49 PM WHEN THE DEVICE WAS CHANNELED OFF. THE TOTAL VOLUME RECORDED AS BEING INFUSED DURING THIS PERIOD WAS 114.188ML. FUNCTIONAL TESTING PERFORMED FOUND THE PUMP MODULE TO BE DELIVERING FLUID WITHIN SPECIFICATION. FUNCTIONAL TESTING OF THE PRIMARY ADMINISTRATION SET WAS NOT PERFORMED DUE TO THE SET WAS RECEIVED DAMAGED. THE UPPER FITMENT WAS BROKEN INTO TWO PIECES AND THE SET WAS SEPARATED AT THIS BREAK. THE SET WAS ALSO CUT APPROXIMATELY 4 INCHES FROM THE MALE LUER. THE ROOT CAUSE OF THE PUMP INFUSING TOO FAST 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.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE RN SETUP AN INFUSION OF D5W AND PROGRAMMED THE INFUSION PUMP TO INFUSE AT 50 ML/HOUR USING A 500 ML BAG. AFTER 10 MINUTES, THE RN REPORTED 400 ML OF FLUID HAD INFUSED. THERE WAS NO PATIENT HARM REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    860063 ALARIS® PUMP MODULE PUMP, INFUSION FRN CAREFUSION SD 8100

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown 8100,8015,(2)2420-0500