BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CADD

    MDR report key: 13972536 · Received April 1, 2022

    Report

    Report Number
    3012307300-2022-05684
    Event Type
    Malfunction
    Date Received
    April 1, 2022
    Report Date
    August 30, 2022
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    FRN
    UDI-DI
    15019517126600
    PMA / PMN Number
    K111275
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    OTHER, OTHER TEXT: 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 THE TAMPER SEAL. ERROR WAS FOUND IN THE DEVICE EHL (EVENT HISTORY LOG) MULTIPLE TIMES. THE CUSTOMER STATED PROBLEM WAS NOT DUPLICATED. NO DEVICE PROBLEM WAS FOUND. THE CAUSE OF THE REPORTED PROBLEM COULD NOT BE DETERMINED. A DHR (DEVICE HISTORY REVIEW) WAS NOT PERFORMED BECAUSE THE RESULTS OF THE COMPLAINT INVESTIGATION DO NOT INDICATE A PROBLEM WITH THE MANUFACTURE OR LAST REPAIR OF THE DEVICE. NO MANUFACTURING OR SERVICE ISSUES WERE IDENTIFIED AS CAUSES OF THE CUSTOMER'S REPORTED PROBLEM DURING THE REVIEW OF SERVICE AND REPAIR RECORDS. THEREFORE, NO MANUFACTURING OR SERVICE RECORDS REVIEW IS NEEDED. B5: CORRECTION: NO PATIENT INJURY WAS REPORTED. D4: CORRECTION: CATALOG NUMBER: 21-2127-0104-01 H6: CORRECTION: EVENT PROBLEM PATIENT CODE: 4582-NO CLINICAL SIGNS, SYMPTOMS OR CONDITIONS C106106

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PUMP CASSETTE LOCK ALARM WAS EXPERIENCED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    872785 CADD PUMP, INFUSION FRN SMITHS MEDICAL ASD, INC. 2120 15019517126600

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown