BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CADD LEGACY PLUS PUMP

    MDR report key: 15385406 · Received September 8, 2022

    Report

    Report Number
    3012307300-2022-18242
    Event Type
    Malfunction
    Date Received
    September 8, 2022
    Report Date
    October 19, 2022
    Manufacturer
    ST PAUL
    Product Code
    FRN
    PMA / PMN Number
    K982838
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    UNIQUE IDENTIFIER (UDI) 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.

    Additional Manufacturer Narrative · 0

    OTHER TEXT: D10: DEVICE AVAILABLE FOR EVALUATION: UPDATED. H3: DEVICE EVALUATED BY MANUFACTURER: UPDATED. H6: EVENT PROBLEM AND EVALUATION CODES: UPDATED. H10: DEVICE EVALUATION: THE DEVICE WAS RETURNED TO MANUFACTURING FOR INVESTIGATION. VISUAL INSPECTION AND FUNCTIONAL TESTING WERE PERFORMED. VISUAL INSPECTION OF THE RETURNED DEVICE CONFIRMED THAT THE TAMPER SEALS AND PHYSICAL CONDITION WERE ALL INTACT UPON RECEIPT. ERROR CODES WERE FOUND IN THE EHL (EVENT HISTORY LOG) MULTIPLE TIMES. THE CUSTOMER REPORTED PROBLEM WAS DUPLICATED DURING THE INVESTIGATION AS THE OCCLUSION DETECTION LEVEL OF THE DOWNSTREAM OCCLUSION SENSOR (DSO) WAS LOW LEVEL AND WITHOUT THE STANDARD. THE ROOT CAUSE OF THE REPORTED EVENT IS UNKNOWN. REPLACE THE DOWNSTREAM SENSOR. A DEVICE HISTORY RECORD DHR REVIEW WAS NOT CONDUCTED, BASED UPON REVIEW OF THE INFORMATION PROVIDED BY THE CUSTOMER, AS IT DOES NOT INDICATE A PROBLEM WITH THE INITIAL MANUFACTURE OR PRIOR REPAIR OF THE DEVICE., CORRECTED DATA: G5: PREMARKET 510K NUMBER: K982838.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DEVICE HAD A HIGH PRESSURE ALARM. NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2122350 CADD LEGACY PLUS PUMP PUMP, INFUSION FRN ST PAUL 6500

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown