BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CADD-LEGACY 1 PUMP

    MDR report key: 16158132 · Received January 13, 2023

    Report

    Report Number
    3012307300-2023-00464
    Event Type
    Malfunction
    Date Received
    January 13, 2023
    Date of Event
    December 8, 2022
    Report Date
    March 17, 2023
    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
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADDITIONAL REPORTABLE INFORMATION BECOMES AVAILABLE. D5 IS UNKNOWN. NO INFORMATION HAS BEEN PROVIDED TO DATE.

    Additional Manufacturer Narrative · 0

    WHILE PERFORMING A REVIEW OF ADDITIONAL INFORMATION PROVIDED BY THE CUSTOMER, THERE WAS NO PATIENT INVOLVEMENT, THEREFORE, NO PATIENT DEATH, SERIOUS INJURY, AND NO EVIDENCE OF A REPORTABLE PRODUCT MALFUNCTION. THE HAZARDOUS SITUATION FOR THE GIVEN COMPLAINT DEVICE WOULD NOT LIKELY CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY IF THE MALFUNCTION WERE TO RECUR. FILE CC-0181887 IS NO LONGER CONSIDERED REPORTABLE, PLEASE DISREGARDS ANY MDRS ASSOCIATED WITH IT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A RETURNED ORDER SERVICE THE DEVICE KEPT SHUTTING OFF AND POWERING BACK ON WHEN THE KEY IS PRESSED. THERE HAS BEEN NO REPORT OF PATIENT INVOLVEMENT OR NO OBSERVABLE CLINICAL SYMPTOMS OR A CHANGE IN SYMPTOMS IDENTIFIED IN THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1963421 CADD-LEGACY 1 PUMP PUMP, INFUSION FRN ST PAUL 6400 10610586019548

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown