BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CADD LEGACY PLUS PUMPS

    MDR report key: 15661545 · Received October 24, 2022

    Report

    Report Number
    3012307300-2022-26073
    Event Type
    Malfunction
    Date Received
    October 24, 2022
    Report Date
    November 18, 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

    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. NO PRODUCT INFORMATION HAS BEEN PROVIDED TO DATE.

    Additional Manufacturer Narrative · 0

    OTHER, OTHER TEXT: D10: DEVICE AVAILABLE FOR EVALUATION: UPDATED. H3: DEVICE EVALUATED BY MANUFACTURER: UPDATED. H6: EVENT PROBLEM AND EVALUATION CODES: UPDATED. H10: DEVICE EVALUATION: A SAMPLE WAS RETURNED TO MANUFACTURING FOR INVESTIGATION. VISUAL INSPECTION AND FUNCTIONAL TESTING WERE PERFORMED. VISUAL INSPECTION OF THE RETURNED DEVICE CONFIRMED THAT ALL LABELS WERE INTACT AND THERE WAS NO PHYSICAL DAMAGE UPON RECEIPT. AN ERROR CODE WAS FOUND IN THE EHL (EVENT HISTORY LOG). THE CUSTOMER REPORTED ISSUE WAS NOT CONFIRMED DURING THE INVESTIGATION AS NO FAULT WAS FOUND. ROOT CAUSE OF THE REPORTED ISSUE IS UNKNOWN AND COULD NOT BE DETERMINED HOWEVER, IT IS POSSIBLE THAT THE DOWNSTREAM OCCLUSION SENSOR OR CASSETTE PRODUCT WAS DEFECTIVE. PREVENTIVELY REPLACED THE DOWNSTREAM OCCLUSION SENSOR AND RECALIBRATED THE UPSTREAM OCCLUSION SENSOR. A REVIEW OF THE MANUFACTURING DEVICE HISTORY RECORD DHR FOR THIS DEVICE FOUND NO CAUSES OR POTENTIAL CAUSES OF THE CUSTOMER REPORTED FAILURE. NO CAUSES OR POTENTIAL CAUSES OF THE CUSTOMER REPORTED PROBLEM WERE FOUND DURING THE REVIEW OF SERVICE AND REPAIR RECORDS., CORRECTED DATA: G5: CORRECTION: PREMARKET 510K NUMBER: K982838.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING THE USE OF THE PRODUCT, AN ALARM WENT OFF SEVERAL TIMES. THEN THE FLOW RATE WAS LOWERED. NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2562754 CADD LEGACY PLUS PUMPS PUMP, INFUSION FRN ST PAUL 6500

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown