BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CADD-LEGACY PLUS AMBULATORY INFUSION SYSTEM

    MDR report key: 15258145 · Received August 19, 2022

    Report

    Report Number
    3012307300-2022-15648
    Event Type
    Malfunction
    Date Received
    August 19, 2022
    Report Date
    September 12, 2022
    Manufacturer
    ST PAUL
    Product Code
    FRN
    PMA / PMN Number
    K982836
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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 REQUIRED. UDI NUMBER AND CATALOG NUMBER IS UNKNOWN. NO INFORMATION HAS BEEN PROVIDED TO DATE.

    Additional Manufacturer Narrative · 0

    H10: DEVICE EVALUATION: THE DEVICE WAS RETURNED FOR INVESTIGATION. A VISUAL INSPECTION AND FUNCTIONAL TEST WERE PERFORMED. VISUAL INSPECTION FOUND THE DEVICE IN GOOD CONDITION. ERROR WAS FOUND IN THE DEVICE EHL (EVENT HISTORY LOG) MULTIPLE TIMES. THE CUSTOMER STATED PROBLEM WAS NOT DUPLICATED. PREVENTIVELY, REPLACED THE DOWNSTREAM OCCLUSION SENSOR AND THE UPSTREAM OCCLUSION SENSOR WAS RE-CALIBRATED. THE CAUSE OF THE REPORTED PROBLEM COULD NOT BE DETERMINED. A DHR (DEVICE HISTORY 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: D4: CORRECTION: CATALOG NUMBER: 21-6500-09. D4: CORRECTION: MODEL NUMBER: 6500.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING THE USE OF THE CASSETTE, A "NO DISPOSABLE, PUMP WON'T RUN" ALARM WENT OFF. THERE WAS NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2190960 CADD-LEGACY PLUS AMBULATORY INFUSION SYSTEM PUMP, INFUSION FRN ST PAUL 6500

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown