BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMITHS MEDICAL ASD, INC

    MDR report key: 20152362 · Received September 5, 2024

    Report

    Report Number
    3012307300-2024-08651
    Event Type
    Malfunction
    Date Received
    September 5, 2024
    Date of Event
    August 1, 2024
    Report Date
    October 4, 2024
    Manufacturer
    SMITHS MEDICAL ASD, INC
    Product Code
    FRN
    UDI-DI
    10610586042829
    PMA / PMN Number
    K111275
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    E1 - INITIAL REPORTER PHONE: (B)(6). B3: UNKNOWN; NO INFORMATION HAS BEEN PROVIDED TO DATE. H3: 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

    ONE DEVICE WAS RETURNED FOR REPAIR. VISUAL EVALUATION OF DEVICE SHOWED MODERATE BUBBLING OF THE DOWNSTREAM OCCLUSION (DSO) SEAL. ERROR HISTORY LOG SHOWED CASSETTE NOT ATTACHED PROPERLY ALARM. SERVICE HISTORY REVIEW IDENTIFIED THE COMPLAINT WAS NOT RELATED TO A PREVIOUS SERVICE OF THE DEVICE WITHIN THE REVIEW PERIOD. THE LAST REPAIR WAS IN JUNE 2022. THE CAUSE OF THE PRIMARY PROBLEM WAS DEGRADED DSO SENSOR. REPLACED DSO SENSOR TO RESOLVE THE REPORT ERROR. THE DEVICE PASSED ALL FUNCTIONAL TESTS AFTER THE REPAIR.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PUMP CASSETTE WAS NOT ATTACHED. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2287525 SMITHS MEDICAL ASD, INC PUMP, INFUSION FRN SMITHS MEDICAL ASD, INC 2120 10610586042829

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown