BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CADD LEGACY 1 PUMP

    MDR report key: 14304827 · Received May 6, 2022

    Report

    Report Number
    3012307300-2022-07683
    Event Type
    Malfunction
    Date Received
    May 6, 2022
    Date of Event
    April 6, 2022
    Report Date
    May 5, 2022
    Manufacturer
    ST PAUL
    Product Code
    FRN
    UDI-DI
    10610586019548
    PMA / PMN Number
    K982838
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A UNRESOLVABLE CADD LEGACY 6400 WITH A NO DISPOSABLE PUMP ALARM USING CASSETTE LOT NUMBER 4220003, EXPIRATION 11/24/2026. CADD LEGACY PUMP SERIAL NUMBER (B)(4). NO FURTHER DETAILS PROVIDED AND NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1437869 CADD LEGACY 1 PUMP PUMP, INFUSION FRN ST PAUL 21-6400-51 10610586019548

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown