BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDFUSION

    MDR report key: 10405297 · Received August 13, 2020

    Report

    Report Number
    3012307300-2020-08171
    Event Type
    Malfunction
    Date Received
    August 13, 2020
    Report Date
    August 13, 2020
    Manufacturer
    ST PAUL
    Product Code
    FRN
    UDI-DI
    10610586032318
    PMA / PMN Number
    K040899
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    INFORMATION RECEIVED A SMITHS MEDICAL AMBULATORY INFUSION PUMPS/CADD CASSETTE RESERVOIRS - FLOW STOP ON THREE DIFFERENT OCCASIONS LOT DOCUMENTED 3935920, 3894451, 3900379 ALARMS UPSTREAM OCCLUSION ALARM. NO PATIENT ADVERSE EVENTS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    866486 MEDFUSION SYRINGE PUMP FRN ST PAUL 3500 10610586032318

    Patients

    Seq Age Sex Outcome Treatment
    1