BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CADD LEGACY 1 PUMPS - 6400

    MDR report key: 15419046 · Received September 14, 2022

    Report

    Report Number
    3012307300-2022-19164
    Event Type
    Malfunction
    Date Received
    September 14, 2022
    Report Date
    March 28, 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.

    Additional Manufacturer Narrative · 0

    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 OF THE DEVICE FOUND THE TAMPER SEAL ALL INTACT, NO PHYSICAL DAMAGE. THERE WAS NO EVIDENCE OF THE REPORTED PROBLEM RECORDED IN THE EVENT HISTORY LOG. THE REPORTED COMPLAINT WAS DUPLICATED. THE INVESTIGATION FOUND BROKEN INTERNAL BACK A PIEZO WIRE. FOR CORRECTIVE ACTION, IT WAS RECOMMENDED TO REPLACE THE A PIEZO. THE ROOT CAUSE OF THE REPORTED PROBLEM WAS UNKNOWN. THIS REMEDIATION MDR WAS GENERATED UNDER PROTOCOL (B)(4), AS A RESULT OF WARNING LETTER CMS# (B)(4). PRODUCT IS BEYOND 19 YEARS FROM MANUFACTURE DATE OF 2003-04 AND THERE WAS NO INDICATION OF A MANUFACTURING DEFECT DURING THE INVESTIGATION, SO A DHR (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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DEVICE HAD A DISTORTED ALARM SOUND. 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
    2496725 CADD LEGACY 1 PUMPS - 6400 PUMP, INFUSION FRN ST PAUL 6400 10610586019548

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown