BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS PUMP MODULE

    MDR report key: 14031173 · Received April 6, 2022

    Report

    Report Number
    2016493-2022-827061
    Event Type
    Malfunction
    Date Received
    April 6, 2022
    Manufacturer
    CAREFUSION SD
    Product Code
    FRN
    UDI-DI
    10885403222054
    PMA / PMN Number
    K133532
    Removal / Correction Number
    Z-1768-2019
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    AT THE TIME OF THE REPORTED FIELD ACTION, CUSTOMERS WERE NOTIFIED. DEVICE REPAIR OR RETURNS WERE HANDLED WITHIN THE SCOPE OF THE FIELD ACTION. NO FURTHER INFORMATION IS AVAILABLE AS THIS IS A RETROSPECTIVE REPORT BASED ON FIELD ACTION AFFECTED SERIAL NUMBERS DATING BACK TO 2011. DEVICE NOT AVAILABLE FOR EVALUATION.

    Description of Event or Problem · 0

    AN 8100 LVP WAS IDENTIFIED AS BEING AFFECTED BY THE BEZEL MECHANICAL ASSEMBLY RECALL. THIS EVENT IS REPORTED RETROSPECTIVE-LY AS A PRESUMPTIVE MALFUNCTION REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1911920 ALARIS PUMP MODULE PUMP, INFUSION FRN CAREFUSION SD 8100 10885403222054

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown