BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDFUSION

    MDR report key: 13290009 · Received January 19, 2022

    Report

    Report Number
    3012307300-2022-01147
    Event Type
    Malfunction
    Date Received
    January 19, 2022
    Report Date
    January 19, 2022
    Manufacturer
    ST PAUL
    Product Code
    FRN
    UDI-DI
    10610586041242
    PMA / PMN Number
    K111386
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ONE SMITHS MEDICAL MEDFUSION PUMP WAS RETURNED FOR ANALYSIS. CRACKED ON RIGHT PLUNGER CASE WAS IDENTIFIED DURING THE PHYSICAL INSPECTION. EVENT LOG HISTORY WAS PERFORMED AND INDICATED THAT FORCE SENSOR TEST ERROR WAS RECORDED IN HISTORY. DURING ANALYSIS, THE REPORTED ISSUE WAS UNABLE TO BE DUPLICATED. BASED ON THE EVIDENCE, THE COMPLAINT WAS NOT CONFIRMED. THE CAUSE OF THE REPORTED ISSUE WAS THE CUSTOMER MANIPULATED THE PUMP DURING IT SELF-TEST, BY ENTERING THE BIOMED CODE 2580 CUSTOMER WAS ABLE TO CLEAR THE FORCE SENSOR TEST ERROR. SERVICE PERFORMED PM MAINTENANCE AND ALL FUNCTIONAL TESTING. 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 CAUSES OR POTENTIAL CAUSES OF THE CUSTOMER'S REPORTED PROBLEM WERE FOUND DURING THE REVIEW OF SERVICE AND REPAIR RECORDS.

    Description of Event or Problem · 0

    ORACLE RO : 1172023 SYSTEM FAILURE: FORCE SENSOR TEST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    888970 MEDFUSION PUMP, INFUSION FRN ST PAUL 3500-0600-01 10610586041242

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown