BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDFUSION

    MDR report key: 11345130 · Received February 18, 2021

    Report

    Report Number
    3012307300-2021-01345
    Event Type
    Injury
    Date Received
    February 18, 2021
    Report Date
    February 18, 2021
    Manufacturer
    ST PAUL
    Product Code
    FRN
    UDI-DI
    10610586043567
    PMA / PMN Number
    K111386
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION COMPLETED ON A SMITHS MEDICAL SYRINGE INFUSION PUMPS/MEDFUSION 4000 PUMPS . THE COMPLAINT OF OCCLUSION OCCURRING RANDOMLY ON DEVICE WAS VERIFIED DURING TESTING AND REVEALED IN EVENT LOG. THE MALFUNCTION WAS ISOLATED TO FORCE SENSOR AND PLUNGER CABLE. DEVICE PHYSICAL CONDITION TOP CASE CHIPPED ON LEFT CORNER AND BOTTOM CASE CRACKED BY L BRACKET. ACTON WAS TAKEN TO REPLACE FORCE SENSOR AND PLUNGER CABLE. PERFORMED CALIBRATION, OCCLUSION TEST, PM AND ALL FUNCTIONAL TESTS WHICH PASSED

    Description of Event or Problem · 1

    INFORMATION RECEIVED A SMITHS MEDICAL SYRINGE INFUSION PUMPS/MEDFUSION 4000 PUMPS OCCLUSION ALARMS HAPPENING RANDOMLY ON DEVICE.. NO PATIENT ADVERSE EVENTS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    241594 MEDFUSION SYRINGE PUMP FRN ST PAUL 4000 10610586043567

    Patients

    Seq Age Sex Outcome Treatment
    1