BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CADD LEGACY 1 PUMP MDL 6400

    MDR report key: 15094182 · Received July 25, 2022

    Report

    Report Number
    3012307300-2022-14079
    Event Type
    Malfunction
    Date Received
    July 25, 2022
    Report Date
    November 2, 2022
    Manufacturer
    ST PAUL
    Product Code
    FRN
    UDI-DI
    10610586019548
    PMA / PMN Number
    K982838
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, 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. DATE OF EVENT AND OPERATOR OF DEVICE ARE UNKNOWN. NO INFORMATION HAS BEEN PROVIDED TO DATE.

    Additional Manufacturer Narrative · 0

    OTHER, OTHER TEXT: H6: EVENT PROBLEM AND EVALUATION CODES: UPDATED. H3: DEVICE EVALUATED BY MANUFACTURER: UPDATED. H10: DEVICE EVALUATION: THE DEVICE WAS RETURNED FOR INVESTIGATION. VISUAL INSPECTION AND FUNCTIONAL TEST WERE PERFORMED. THE CUSTOMERS REPORTED PROBLEM WAS NOT RELATED TO ANY PREVIOUS REPAIR. VISUAL INSPECTION FOUND THE DEVICE IN GOOD CONDITION, ALL WAS INTACT. THERE WAS NO EVIDENCE OF THE ERROR, OR THE REPORTED PROBLEM RECORDED IN THE EVENT HISTORY LOG. THE REPORTED PROBLEM WAS NOT DUPLICATED. NO FAULT WAS FOUND. FOR CORRECTIVE ACTION THE DOWNSTREAM OCCLUSION SENSOR WAS REPLACED AS A PREVENTATIVE MEASURE. THE ROOT CAUSE OF THE REPORTED PROBLEM WAS UNKNOWN. PRODUCT IS BEYOND 18 YEARS FROM MANUFACTURE DATE OF 2004-03 AND THERE WAS NO INDICATION OF A MANUFACTURING DEFECT DURING THE INVESTIGATION, SO A DEVICE HISTORY RECORD REVIEW WAS NOT PERFORMED. A SERVICE HISTORY REVIEW IDENTIFIED THIS DEVICE HAS NOT BEEN IN FOR SERVICE IN THE PREVIOUS YEAR AND THERE WAS NO INDICATION OF A SERVICE ISSUE DURING THE INVESTIGATION., CORRECTED DATA: CORRECTION: D4: MODEL NUMBER: 6400

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AN ERROR MESSAGE NO DISPOSABLE PUMP-WILL NOT RUN OCCURRED. NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1553352 CADD LEGACY 1 PUMP MDL 6400 PUMP, INFUSION FRN ST PAUL 6400 10610586019548

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown