BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS PCA

    MDR report key: 10674160 · Received October 13, 2020

    Report

    Report Number
    2016493-2020-20741
    Event Type
    Malfunction
    Date Received
    October 13, 2020
    Report Date
    September 16, 2020
    Manufacturer
    CAREFUSION SD
    Product Code
    FRN
    UDI-DI
    10885403812002
    PMA / PMN Number
    K032233
    Removal / Correction Number
    Z-2882-2020
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    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 THAT (79) PCA/SYRINGE SIZER SENSOR IS BEING REPLACED. THE CUSTOMER CONFIRMED THAT THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1134653 ALARIS PCA PUMP, INFUSION FRN CAREFUSION SD 8120 10885403812002

    Patients

    Seq Age Sex Outcome Treatment
    1