BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CADD LEGACY 1 PUMPS - 6400

    MDR report key: 15764712 · Received November 9, 2022

    Report

    Report Number
    3012307300-2022-26994
    Event Type
    Malfunction
    Date Received
    November 9, 2022
    Report Date
    July 24, 2023
    Manufacturer
    ST PAUL
    Product Code
    FRN
    UDI-DI
    10610586019548
    PMA / PMN Number
    K982838
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATION: ONE DEVICE WAS RETURNED FOR ANALYSIS IN USED CONDITION. VISUAL INSPECTION SHOWED FLUID INGRESSION ON THE DOWNSTREAM OCCLUSION SENSOR. REVIEW OF THE EVENT HISTORY LOG SHOWED OCCURRENCES OF "NO DISPOSABLE" MESSAGES. THE REPORTED ISSUE WAS NOT DUPLICATED DURING FUNCTIONAL TESTING. ACCURACY TESTING FOUND THE PUMP TO BE WITHIN SPECIFICATIONS. THE INVESTIGATION DETERMINED THE FLUID INGRESSION TO BE A POSSIBLE, BUT UNCONFIRMED CAUSE OF THE REPORTED ISSUE. THE DOWNSTREAM OCCLUSION SENSOR WAS REPLACED. SERVICE HISTORY REVIEW IDENTIFIED THIS DEVICE HAS NOT BEEN IN FOR SERVICE IN THE PREVIOUS 12 MONTHS AND THERE WAS NO INDICATION THAT THE COMPLAINT WAS RELATED TO A PREVIOUS SERVICE OF THE DEVICE. A MANUFACTURING DHR REVIEW WAS NOT PERFORMED BECAUSE THE DEVICE IS BEYOND A YEAR FROM ITS MANUFACTURE DATE OF (2004-03) AND THERE WAS NO INDICATION OF A MANUFACTURING DEFECT DURING THE INVESTIGATION.

    Additional Manufacturer Narrative · 0

    OPERATOR OF DEVICE IS 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DEVICE STOPPED WORKING. 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
    2954709 CADD LEGACY 1 PUMPS - 6400 PUMP, INFUSION FRN ST PAUL 6400 10610586019548

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown