BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLUM 360 DRIVER NEW

    MDR report key: 9537949 · Received January 2, 2020

    Report

    Report Number
    9615050-2020-00001
    Event Type
    Malfunction
    Date Received
    January 2, 2020
    Date of Event
    November 22, 2019
    Report Date
    December 6, 2019
    Manufacturer
    ICU MEDICAL COSTA RICA LTD.
    Product Code
    FRN
    PMA / PMN Number
    K141789
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H10: THE DEVICE WAS RETURNED TO THE MANUFACTURER JANUARY 8, 2020 FOR EVALUATION. DEVICE TESTING COULD NOT CONFIRM THE CUSTOMER'S COMPLAINT THAT THE PUMP HAS AIR TRAVELED THROUGH CASSETTE INTO DISTAL SIDE OF THE LINE. THE TESTING LAB TESTED THIS PUMP WITH THE NON-SERIALIZED DEVICES LISTED. THE PROBABLE CAUSE NOT FOUND.

    Additional Manufacturer Narrative · 1

    POSSIBLE LOT NUMBERS FOR THE CONCOMITANT PLUM SET (4102122, 4015857, 4099967, 4099959). THE DEVICE IS EXPECTED TO RETURN TO THE MANUFACTURER FOR INVESTIGATION; IT HAS NOT YET BEEN RECEIVED.

    Description of Event or Problem · 1

    THE EVENT INVOLVED A PLUM 360 DEVICE THAT ALLOWED AIR TO TRAVEL THROUGH THE CASSETTE TO THE DISTAL SIDE OF THE LINE AND THE EVENT WAS NOT NOTED IN THE DEVICE HISTORY LOG. THERE WAS NO REPORT OF PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1250 PLUM 360 DRIVER NEW PUMP, INFUSION FRN ICU MEDICAL COSTA RICA LTD.

    Patients

    Seq Age Sex Outcome Treatment
    1 PLUM SET, MFR ICU MEDICAL