BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS PCA

    MDR report key: 10997295 · Received December 13, 2020

    Report

    Report Number
    2016493-2020-66474
    Event Type
    Malfunction
    Date Received
    December 13, 2020
    Report Date
    November 17, 2020
    Manufacturer
    CAREFUSION SD
    Product Code
    MEA
    UDI-DI
    10885403812002
    PMA / PMN Number
    K043299
    Removal / Correction Number
    Z-2824-2020
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 0

    CUSTOMERS RECEIVED NOTIFICATION OF THE FIELD ACTION. DEVICE REPAIR OR RETURNS ARE HANDLED WITHIN THE SCOPE OF THE FIELD ACTION. NO FURTHER INFORMATION WILL BE PROVIDED BY THE CUSTOMERS DUE TO THE FIELD ACTION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT ALLEGEDLY THE DISPLAY SEGMENTS WERE DIM FOR THE SIXTY PCA MODULE, AND THEREFORE, WILL BE REPLACED. THERE WAS NO REPORTED PATIENT INVOLVEMENT.

    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 ALLEGEDLY THE DISPLAY SEGMENTS WERE DIM FOR THE SIXTY PCA MODULE, AND THEREFORE, WILL BE REPLACED. THERE WAS NO REPORTED PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1462645 ALARIS PCA PUMP, INFUSION MEA CAREFUSION SD 8120 10885403812002

    Patients

    Seq Age Sex Outcome Treatment
    1