BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLUM 360 DRIVER NEW

    MDR report key: 20474933 · Received October 17, 2024

    Report

    Report Number
    9615050-2024-00766
    Event Type
    Malfunction
    Date Received
    October 17, 2024
    Date of Event
    September 18, 2024
    Report Date
    November 1, 2024
    Manufacturer
    ICU MEDICAL COSTA RICA LTD.
    Product Code
    FRN
    PMA / PMN Number
    K141789
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    TESTS: SELF-TEST AND VISUAL INSPECTION. SELF-TEST FAILED DUE TO NOT TURNING ON AND SMOKE FROM THE DRIVER MOTOR PRINTED WIRING ASSEMBLY (PWA) BOARD. VISUAL INSPECTION PERFORMED AND FOUND TWO COMPONENTS WERE BURNT ON THE DRIVER PWA BOARD AND ONE COMPONENT WAS BURNT ON THE POWER SUPPLY PWA BOARD. THE CUSTOMER COMPLAINT WAS CONFIRMED THAT THE DEVICE DID NOT TURN ON AND SMOKE FROM THE DRIVER BOARD. THE PROBABLE CAUSE WAS A BURNT POWER SUPPLY PWA BOARD AND A BURNT DRIVER MOTOR PWA BOARD. FURTHERMORE, THE SERIAL NUMBER ON THE POWER SUPPLY PWA BOARD: (B)(6), DIDN'T MATCH THE ONE INSTALL BASE RECORDS, AND THE TAB ON THE MAIN CHASSIS WAS DAMAGED.

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS RETURNED FOR EVALUATION; HOWEVER, TESTING HAS NOT YET BEEN COMPLETED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PLUM 360 PUMP BEGAN TO SMOKE FOLLOWING THE INSTALLATION OF A NEW POWER SUPPLY. THIS WAS DURING SET-UP. THERE WAS NO PATIENT INVOLVEMENT AND NO PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1276826 PLUM 360 DRIVER NEW PUMP, INFUSION FRN ICU MEDICAL COSTA RICA LTD.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown