BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS PUMP MODULE

    MDR report key: 8075358 · Received November 15, 2018

    Report

    Report Number
    2016493-2018-00823
    Event Type
    Malfunction
    Date Received
    November 15, 2018
    Date of Event
    October 19, 2018
    Report Date
    October 19, 2018
    Manufacturer
    CAREFUSION
    Product Code
    FRN
    UDI-DI
    10885403810015
    PMA / PMN Number
    K950419
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THAT AN UNSPECIFIED INFUSION WAS PROGRAMMED AT A RATE OF 2.5 ML/HR. IT WAS REPORTED THAT THE " PUMP RANG OFF VOLUME DELIVERED" THE USER NOTED THE RATE DISPLAYED AS 10ML/HR. AND THE IV BAG HAD APPROXIMATELY 15-20 ML REMAINING. THE LIPID INFUSION WAS PAUSED, OTHER INFUSIONS IN USE AT THE TIME OF THE EVENT WERE NOT SPECIFIED. THE EVENT OCCURRED IN THE ICN- INTENSIVE CARE UNIT. THE FACILITY BIOMED PERFORMED A TEST INFUSION AND DOWN LOADED THE EVENT LOGS WHICH DETERMINED THE OVER INFUSION WAS A PROGRAMMING ERROR, THERE ARE NO DEVICES COMING IN FOR INVESTIGATION.

    Additional Manufacturer Narrative · 1

    NO DEVICE WILL BE RETURNED PER CUSTOMER. THE CUSTOMER COMPLAINT COULD NOT BE CONFIRMED BECAUSE THE DEVICE WAS NOT SEQUESTERED FOR FAILURE INVESTIGATION. THE ROOT CAUSE OF THIS FAILURE WAS NOT IDENTIFIED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT AN UNSPECIFIED INFUSION WAS PROGRAMMED AT A RATE OF 2.5 ML/HR. THE DEVICE ALARMED FOR NEOI( NEAR END OF INFUSION) THE USER NOTED THE RATE DISPLAYED AS 10ML/HR. AND THE IV BAG HAD APPROXIMATELY 15-20 ML REMAINING. THE LIPID INFUSION WAS PAUSED, OTHER INFUSIONS IN USE AT THE TIME OF THE EVENT WERE NOT SPECIFIED. THE EVENT OCCURRED IN THE ICN- INTENSIVE CARE UNIT. THE FACILITY BIOMED PERFORMED A TEST INFUSION AND DOWN LOADED THE EVENT LOGS WHICH DETERMINED THE OVER INFUSION WAS A PROGRAMMING ERROR, THERE ARE NO DEVICES COMING IN FOR INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    913980 ALARIS PUMP MODULE PUMP, INFUSION FRN CAREFUSION 8100 10885403810015

    Patients

    Seq Age Sex Outcome Treatment
    1 (2)8015,(3)PRI TUBING,(2)8100, TD (B)(6) 2018