BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDFUSION

    MDR report key: 9951729 · Received April 11, 2020

    Report

    Report Number
    3012307300-2020-02857
    Event Type
    Malfunction
    Date Received
    April 11, 2020
    Date of Event
    March 5, 2020
    Report Date
    April 11, 2020
    Manufacturer
    SMITHS MEDICAL ASD,INC
    Product Code
    FRN
    UDI-DI
    10610586040818
    PMA / PMN Number
    K111386
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION COMPLETED ON A SMITHS MEDICAL MEDFUSION 4000 PUMP. PHYSICAL CONDITION OF DEVICE WAS NOT IN GOOD SHAPE. CRACKED CASE TOP AND ALL CORNERS, CASE BOTTOM BY L- BRACKET AND RIGHT PLUNGER CASE. NO ALARM IN EVENT LOG AND VISUAL INSPECTION CONFIRMED COMPLAINT. IT WAS DISCOVERED CONTAMINATION ON MAIN BOARD AND INTERCONNECT BOARD. ENGINEER FELT DEVICE WAS NOT HANDLED WITH CARE. DEVICE WAS REBUILT AND CAUSE ISOLATED TO MAIN PCB BOARD AND INTERCONNECT BOARD. ONCE REPAIRS COMPLETED, DEVICE PASSED ALL TESTING.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED INDICATING THAT WHILE TURNING ON A SMITHS MEDICAL CADD MEDFUSION 40000 ALARM OCCURRED. DAMAGED UPPER/LOWER CASES/CONTAMINATION MAIN PCB. NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    415083 MEDFUSION PUMP, INFUSION FRN SMITHS MEDICAL ASD,INC 4000 10610586040818

    Patients

    Seq Age Sex Outcome Treatment
    1