BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLUM 360 DRIVER NEW

    MDR report key: 13568154 · Received February 21, 2022

    Report

    Report Number
    9615050-2022-00022
    Event Type
    Malfunction
    Date Received
    February 21, 2022
    Date of Event
    January 1, 2022
    Report Date
    January 26, 2022
    Manufacturer
    ICU MEDICAL COSTA RICA LTD.
    Product Code
    FRN
    PMA / PMN Number
    K161469
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    RECEIVED THE ACTUAL DEVICE. THE CUSTOMER'S COMPLAINT THAT THE DEVICE HAS AN ABNORMAL ODOR OF SMOKE OR SOMETHING BURNT WAS CONFIRMED. THE DEVICE FAILS TO POWER ON CORRECTLY IN AC AND DC POWER MODES AND SMELLS OF HEAVY SMOKE AND BURNT COMPONENTS. INSPECTED EACH ASSEMBLY FOR DAMAGED DUE TO OVERHEATED OR SHORTING OUT. REPLACED THE MAIN POWER SUPPLY, CENTRAL PROCESSING UNIT (CPU) PRINTED WIRING ASSEMBLY (PWA), MECHANISM DRIVER CABLE, MECHANISM DRIVER BOARD PRINTED WIRING ASSEMBLY (PWA), APP PRINTED WIRING ASSEMBLY (PWA) AND PRESSURE DETECTOR SENSOR. CALIBRATED MECHANISM. MECHANISM PASSED CALIBRATION. DEVICE PASSED SELF-TEST. THE PROBABLE CAUSE FOR THE CUSTOMER'S COMPLAINT OF SMOKE OR ABNORMAL ODOR IS BURNT COMPONENTS SUCH AS THE MAIN POWER SUPPLY, CENTRAL PROCESSING UNIT (CPU), MECHANISM DRIVER CABLE, MECHANISM DRIVER BOARD, APP PRINTED WIRING ASSEMBLY (PWA) AND PRESSURE DETECTOR SENSOR.

    Additional Manufacturer Narrative · 0

    RECEIVED THE ACTUAL DEVICE. THE CUSTOMER'S COMPLAINT THAT THE DEVICE HAS AN ABNORMAL ODOR OF SMOKE OR SOMETHING BURNT WAS CONFIRMED. THE DEVICE FAILS TO POWER ON CORRECTLY IN AC AND DC POWER MODES AND SMELLS OF HEAVY SMOKE AND BURNT COMPONENTS. INSPECTED EACH ASSEMBLY FOR DAMAGED DUE TO OVERHEATED OR SHORTING OUT. REPLACED THE MAIN POWER SUPPLY, CENTRAL PROCESSING UNIT (CPU) PRINTED WIRING ASSEMBLY (PWA), MECHANISM DRIVER CABLE, MECHANISM DRIVER BOARD PRINTED WIRING ASSEMBLY (PWA), APP PRINTED WIRING ASSEMBLY (PWA) AND PRESSURE DETECTOR SENSOR. CALIBRATED MECHANISM. MECHANISM PASSED CALIBRATION. DEVICE PASSED SELF-TEST. THE PROBABLE CAUSE FOR THE CUSTOMER'S COMPLAINT OF SMOKE OR ABNORMAL ODOR IS BURNT COMPONENTS SUCH AS THE MAIN POWER SUPPLY, CENTRAL PROCESSING UNIT (CPU), MECHANISM DRIVER CABLE, MECHANISM DRIVER BOARD, APP PRINTED WIRING ASSEMBLY (PWA) AND PRESSURE DETECTOR SENSOR.

    Description of Event or Problem · 0

    THE EVENT INVOLVED A PLUM 360 PUMP WHERE THE NURSES REPORTED "SMOKE COMING OUT OF THE DEVICE". A TECHNICIAN TOOK THE BATTERY OUT AND THE DEVICE WAS SENT IT OUT FOR REPAIR. THERE WAS NO DAMAGED TO THE AC POWER CORD AND NO EXPOSED BARE WIRES NOTED. THERE WAS NO PATIENT INVOLVEMENT AND NO HUMAN HARM.

    Description of Event or Problem · 0

    THE EVENT INVOLVED A PLUM 360 PUMP WHERE THE NURSES REPORTED "SMOKE COMING OUT OF THE DEVICE". A TECHNICIAN TOOK THE BATTERY OUT AND THE DEVICE WAS SENT IT OUT FOR REPAIR. THERE WAS NO DAMAGED TO THE AC POWER CORD AND NO EXPOSED BARE WIRES NOTED. THERE WAS NO PATIENT INVOLVEMENT AND NO HUMAN HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1674250 PLUM 360 DRIVER NEW PUMP, INFUSION FRN ICU MEDICAL COSTA RICA LTD.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown