BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CADD

    MDR report key: 10258130 · Received July 10, 2020

    Report

    Report Number
    3012307300-2020-07161
    Event Type
    Malfunction
    Date Received
    July 10, 2020
    Report Date
    August 25, 2020
    Manufacturer
    ST PAUL
    Product Code
    FRN
    UDI-DI
    10610586019548
    PMA / PMN Number
    K982838
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    ORACLE RO 1073543: DEVICE GETTING "AIR IN LINE DETECTED" ERROR REPEATEDLY. ADDITIONAL INFORMATION RECEIVED ON 30-JUN-2020: NO FURTHER INFORMATION AVAILABLE. INVESTIGATION COMPLETED ON A SMITHS MEDICAL CADD LEGACY 6400 PUMP.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED THAT THIS SMITHS MEDICAL CADD LEGACY PUMP EXHIBITED "AIR IN LINE DETECTED" AND CONTINUOUS ERROR. NO REPORTED ADVERSE EFFECTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    724496 CADD LEGACY FRN ST PAUL 6400 10610586019548

    Patients

    Seq Age Sex Outcome Treatment
    1