BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CADD

    MDR report key: 14115801 · Received April 14, 2022

    Report

    Report Number
    3012307300-2022-06422
    Event Type
    Malfunction
    Date Received
    April 14, 2022
    Report Date
    June 14, 2022
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    FRN
    UDI-DI
    15019517150001
    PMA / PMN Number
    K111275
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    OTHER, OTHER TEXT: B5: ADDITIONAL INFORMATION RECEIVED BY SMITHS MEDICAL/ICU ON 25-MAY-2022 VIA EMAIL: EVENT DID NOT OCCUR WHILE IN USE BY PATIENT. FOUND DURING TESTING. H6: EVENT PROBLEM AND EVALUATION CODES: UPDATED H10: DEVICE EVALUATION: THE DEVICE WAS RETURNED FOR INVESTIGATION. A VISUAL INSPECTION AND FUNCTIONAL TEST WERE PERFORMED. VISUAL INSPECTION FOUND THE DEVICE WAS MISSING TAMPER SEAL. EVENT HISTORY LOG WAS REVIEWED AND THE ERROR WAS FOUND MULTIPLE TIMES. THE CUSTOMER STATED PROBLEM WAS DUPLICATED. REPLACED DEFECTIVE DSO (DOWNSTREAM OCCLUSION) SENSOR. THE CAUSE OF THE REPORTED PROBLEM COULD NOT BE DETERMINED. A MANUFACTURING DHR REVIEW WAS NOT PERFORMED BECAUSE THE RESULTS OF THE COMPLAINT INVESTIGATION DO NOT INDICATE A PROBLEM WITH THE MANUFACTURE OF THE DEVICE. NO MANUFACTURING RELATED CAUSES OR POTENTIAL CAUSES OF THE CUSTOMER'S REPORTED PROBLEM WERE FOUND DURING THE REVIEW OF SERVICE AND REPAIR RECORDS. THEREFORE, NO MANUFACTURING DHR REVIEW IS NEEDED.

    Description of Event or Problem · 0

    ORACLE RO 1221220: REASON FOR RETURN: NOT DETECTING SET.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2584462 CADD PUMP, INFUSION FRN SMITHS MEDICAL ASD, INC. 21-2120-0105-01 15019517150001

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown