BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLUM 360 DRIVER ITALIAN

    MDR report key: 18744367 · Received February 20, 2024

    Report

    Report Number
    9615050-2024-00148
    Event Type
    Malfunction
    Date Received
    February 20, 2024
    Date of Event
    January 11, 2024
    Report Date
    January 12, 2024
    Manufacturer
    ICU MEDICAL COSTA RICA LTD.
    Product Code
    FRN
    PMA / PMN Number
    K141789
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    DURING INVESTIGATION, THE DEVICE WOULD NOT POWER ON. THE DEVICE EVENT LOG/ALARM HISTORY WAS REVIEWED AND NO RELEVANT ALARMS WERE IDENTIFIED. THERE WAS A SMELL OF BURNING FROM THE DEVICE. THE DEVICE WAS OPENED AND IT WAS FOUND THAT BOTH THE POWER SUPPLY PRINTED WIRE ASSEMBLY (PWA) AND MOTOR DRIVER PWA HAD SIGNS OF BURNING; THERE WAS MELTED COMPONENT MATERIAL ON BOTH BOARDS. THE COMPLAINT WAS CONFIRMED. THE PROBABLE CAUSE WAS DAMAGED PWAS. BOTH THE POWER SUPPLY PWA AND MOTOR DRIVER PWA WERE REPLACED. THE MECHANISM WAS FULLY CALIBRATED. THE FLUID SHIELD AND DOOR WERE REPLACED. THE DEVICE PASSED ALL FURTHER TESTING.

    Description of Event or Problem · 0

    THE COMPLAINT/EVENT INVOLVED A PLUM 360 DRIVER ITALIAN THAT REPORTEDLY HAD A BURNING SMELL. THERE WAS NO PATIENT INVOLVEMENT, NO ADVERSE EVENT OR HUMAN HARM, NO DEATH AND NO NEED FOR MEDICAL INTERVENTION. UPON OPENING THE DEVICE FOR INVESTIGATION/EVALUATION, THERE WAS A SMELL OF BURNING COMING FROM THE DEVICE AND BOTH THE POWER SUPPLY PWA AND MOTOR DRIVER PWA HAD MELTED COMPONENT MATERIAL ON EACH OF THE BOARDS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    466172 PLUM 360 DRIVER ITALIAN PUMP, INFUSION FRN ICU MEDICAL COSTA RICA LTD.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown