BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CADD LEGACY 1 PUMP MDL 6400

    MDR report key: 15084786 · Received July 22, 2022

    Report

    Report Number
    3012307300-2022-13957
    Event Type
    Malfunction
    Date Received
    July 22, 2022
    Report Date
    March 30, 2023
    Manufacturer
    ST PAUL
    Product Code
    FRN
    UDI-DI
    10610586019548
    PMA / PMN Number
    K982838
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    003

    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 INFORMATION HAS BEEN PROVIDED TO DATE.

    Additional Manufacturer Narrative · 0

    OTHER TEXT: H6: EVENT PROBLEM AND EVALUATION CODES: UPDATED. D10: DEVICE AVAILABLE FOR EVALUATION: UPDATED. H10: DEVICE EVALUATION: THE DEVICE WAS RETURNED FOR INVESTIGATION. VISUAL INSPECTION AND FUNCTIONAL TEST WERE PERFORMED. THE CUSTOMER REPORTED PROBLEM WAS NOT RELATED TO ANY PREVIOUS REPAIR. VISUAL INSPECTION FOUND THE DEVICE WITH TAMPER SEALS ALL INTACT AND SIGNS OF FLUID INGRESSION ON THE DOWNSTREAM SENSOR. THERE WAS NO EVIDENCE OF THE ERROR RECORDED IN THE EVENT HISTORY LOG. THE CUSTOMER REPORTED PROBLEM WAS NOT VERIFIED. RUNNING THREE ACCURACY TESTS, THE PUMP WAS FOUND TO BE WITHIN MANUFACTURING SPECIFICATIONS. NO FAULT WAS FOUND WITH THE DEVICE. THE REPORTED PROBLEM WAS NOT CONFIRM. NO CORRECTIVE ACTIONS WERE TAKEN. THIS REMEDIATION MDR WAS GENERATED UNDER PROTOCOL B10010579, AS A RESULT OF WARNING LETTER CMS# 617147. PRODUCT IS BEYOND 19 YEARS FROM MANUFACTURE DATE OF 2003-08 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 2 YEARS 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 THE DEVICE FAILED ACCURACY 8.65% DURING TESTING. NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    117310 CADD LEGACY 1 PUMP MDL 6400 PUMP, INFUSION FRN ST PAUL 6400 10610586019548

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown