BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS PUMP MODULE

    MDR report key: 8961622 · Received September 4, 2019

    Report

    Report Number
    2016493-2019-01141
    Event Type
    Malfunction
    Date Received
    September 4, 2019
    Date of Event
    August 5, 2019
    Report Date
    August 7, 2019
    Manufacturer
    CAREFUSION
    Product Code
    FRN
    UDI-DI
    10885403810015
    PMA / PMN Number
    K950419
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER¿S EXPERIENCE OF A RATE/DOSE CHANGE WAS CONFIRMED IN THE PCU EVENT LOG. THE PCU EVENT LOG SHOWED THAT THE DOSE OF 36.91 UNIT/KG/HR WAS INITIALLY CHANGED BY A USER AT (B)(6) 2019 AND WAS FOLLOWED BY A REMOTE IV REQUEST AT (B)(6) 2019. THE ROOT CAUSE OF THE CUSTOMER¿S EXPERIENCE OF A RATE/DOSE CHANGE WAS IDENTIFIED AS DUE TO USER PROGRAMMING.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED AN UNEXPECTED DOSE CHANGE DURING A HEPARIN INFUSION. ON (B)(6) 2019 THE DOSE CHANGED FROM 19 UNIT/KG/H TO 36.91 UNIT/KG/H, HOWEVER IT IS NOT KNOWN HOW OR WHY THE DOSE WAS CHANGED. TEN SECONDS PREVIOUS TO THIS DOSE CHANGE, THE VTBI WAS ADJUSTED AS THE INFUSION HAD TRANSITIONED TO KVO. THE CUSTOMER REQUESTED AN EVENT LOG REVIEW TO DETERMINE THE KEY PRESSES FOR HEPARIN INFUSION FROM (B)(6) 2019 1600 ¿ (B)(6) 2019 2000.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    755516 ALARIS PUMP MODULE PUMP, INFUSION FRN CAREFUSION 8100 10885403810015

    Patients

    Seq Age Sex Outcome Treatment
    1 Congenital Anomaly