BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CADD LEGACY PLUS PUMP

    MDR report key: 15470139 · Received September 23, 2022

    Report

    Report Number
    3012307300-2022-20190
    Event Type
    Malfunction
    Date Received
    September 23, 2022
    Report Date
    October 19, 2022
    Manufacturer
    ST PAUL
    Product Code
    FRN
    PMA / PMN Number
    K982838
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    UNIQUE IDENTIFIER (UDI) AND PROTOCOL # ARE UNKNOWN. NO INFORMATION HAS BEEN PROVIDED TO DATE. 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.

    Additional Manufacturer Narrative · 0

    DEVICE AVAILABLE FOR EVALUATION: UPDATED. H3: DEVICE EVALUATED BY MANUFACTURER: UPDATED. H6: EVENT PROBLEM AND EVALUATION CODES: UPDATED. H10: DEVICE EVALUATION: THE DEVICE WAS RETURNED TO MANUFACTURING FOR INVESTIGATION. VISUAL INSPECTION AND FUNCTIONAL TESTING WERE PERFORMED. VISUAL INSPECTION OF THE RETURNED DEVICE CONFIRMED THAT THE TAMPER SEALS AND PHYSICAL CONDITION WERE ALL INTACT UPON RECEIPT. ERROR CODE WAS FOUND IN THE EHL (EVENT HISTORY LOG). THE CUSTOMER REPORTED PROBLEM WAS NOT DUPLICATED DURING THE INVESTIGATION. THE ROOT CAUSE OF THE REPORTED EVENT IS UNKNOWN AS NO FAULT WAS FOUND. PREVENTIVELY, REPLACE THE DOWNSTREAM SENSOR. A DEVICE HISTORY RECORD DHR REVIEW WAS NOT CONDUCTED, BASED UPON REVIEW OF THE INFORMATION PROVIDED BY THE CUSTOMER, AS IT DOES NOT INDICATE A PROBLEM WITH THE INITIAL MANUFACTURE OR PRIOR REPAIR OF THE DEVICE., CORRECTED DATA: G5: CORRECTION: PREMARKET 510K NUMBER: K982838.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DEVICE HAD A NO DISPOSABLE ALARM. THERE HAS BEEN NO REPORT OF OBSERVABLE CLINICAL SYMPTOMS OR A CHANGE IN SYMPTOMS IDENTIFIED IN THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    553499 CADD LEGACY PLUS PUMP PUMP, INFUSION FRN ST PAUL 6500

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown