BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CADD LEGACY PCA PUMPS

    MDR report key: 16023177 · Received December 21, 2022

    Report

    Report Number
    3012307300-2022-28052
    Event Type
    Malfunction
    Date Received
    December 21, 2022
    Report Date
    January 10, 2023
    Manufacturer
    ST PAUL
    Product Code
    MEA
    PMA / PMN Number
    K982839
    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

    H10: DEVICE EVALUATION: THE DEVICE WAS RETURNED FOR INVESTIGATION. A VISUAL INSPECTION AND FUNCTIONAL TEST WERE PERFORMED. VISUAL INSPECTION FOUND THE DEVICE IN GOOD CONDITION. ERROR WAS FOUND IN THE DEVICE EHL (EVENT HISTORY LOG) MULTIPLE TIMES. THE CUSTOMER STATED PROBLEM WAS NOT DUPLICATED. NO FAULT WAS FOUND WITH THE DEVICE. BY CUSTOMER REQUEST, IT WAS RETURNED TO THE CUSTOMER WITHOUT REPAIR. THE CAUSE OF THE REPORTED PROBLEM COULD NOT BE DETERMINED. A DHR (DEVICE HISTORY REVIEW) WAS PERFORMED AND NO PROBLEMS OR ISSUES WERE IDENTIFIED DURING THIS DHR REVIEW., CORRECTED DATA: D4: CORRECTION: CATALOG NUMBER: 21-6500-09. D4: CORRECTION: MODEL NUMBER: 6500.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PUMP EXHIBITED A NO MESSAGE ALARM DURING USE. 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
    2143361 CADD LEGACY PCA PUMPS PUMP, INFUSION PCA MEA ST PAUL 6500

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown