BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLUM 360¿ INFUSER

    MDR report key: 17135753 · Received June 15, 2023

    Report

    Report Number
    9615050-2023-00176
    Event Type
    Malfunction
    Date Received
    June 15, 2023
    Date of Event
    April 1, 2023
    Report Date
    June 15, 2023
    Manufacturer
    ICU MEDICAL COSTA RICA LTD.
    Product Code
    FRN
    PMA / PMN Number
    K161469
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE CUSTOMER¿S REPORTED CONDITION WAS THAT THE DEVICE HAD INTERNAL ISSUES. THE DEVICE WAS RETURNED FOR EVALUATION AND FAILED THE SELF-TEST, IT WOULD NOT TURN ON. THE REPORTED CONDITION WAS CONFIRMED. THE DRIVER MOTOR PRINTED WIRING ASSEMBLY (PWA) BOARD, PLUNGER MOTOR, I/O MOTOR, INTERFACE CABLE AND FLEX DRIVER MOTOR CABLE WERE REPLACED. CHARRING FOUND ON THE DRIVER MOTOR PWA BOARD. THE PROBABLE CAUSE IS CONTAMINATION GOT ON THE DRIVER MOTOR PWA BOARD AND CAUSES IT TO GET BURNT AND CONTAMINATION GOT ON THE PLUNGER MOTOR AND I/O MOTOR.

    Description of Event or Problem · 0

    THE EVENT INVOLVED A PLUM 360¿ INFUSER ON AN UNKNOWN DATE FOR INTERNAL ISSUES. THE EVENT OCCURRED DURING TESTING. WHEN THE SAMPLE WAS RECEIVED FOR THE INVESTIGATION, IT WAS FOUND THAT CHURRING FOUND ON THE DRIVER MOTOR PWA BOARD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2094211 PLUM 360¿ INFUSER PUMP, INFUSION FRN ICU MEDICAL COSTA RICA LTD.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown