BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS PUMP MODULE

    MDR report key: 9319491 · Received November 13, 2019

    Report

    Report Number
    2016493-2019-01463
    Event Type
    Malfunction
    Date Received
    November 13, 2019
    Report Date
    October 21, 2019
    Manufacturer
    CAREFUSION
    Product Code
    FRN
    PMA / PMN Number
    K133532
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED PER BIOMED THAT OVER THE PAST FEW WEEKS SINCE WE HAVE DEPLOYED OUR NEW LVP¿S WE HAVE RUN INTO SEVERAL INSTANCES IN WHICH THE LVP¿S DO NOT TIGHTLY CONNECT TO THE PC MODULE. THE BIOMED STATED; "WE ARE GUESSING THIS IS DUE TO THE AGE OF OUR PC MODULES." ALTHOUGH REQUESTED THERE WAS NO ADDITIONAL EVENT DETAILS FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1112327 ALARIS PUMP MODULE PUMP, INFUSION FRN CAREFUSION 8100

    Patients

    Seq Age Sex Outcome Treatment
    1