BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLUM 360 DRIVER FRENCH

    MDR report key: 8361385 · Received February 22, 2019

    Report

    Report Number
    9615050-2019-00052
    Event Type
    Malfunction
    Date Received
    February 22, 2019
    Date of Event
    January 1, 2019
    Report Date
    February 1, 2019
    Manufacturer
    ICU MEDICAL COSTA RICA LTD.
    Product Code
    FRN
    PMA / PMN Number
    K141789
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS RETURNED FOR EVALUATION. TESTING VISUALLY CONFIRMED BURNT PWA COMPONENTS. THE PLUNGER MOTOR CAUSED THE BURNING ISSUE ON THE DRIVER AND POWER SUPPLY PWAS. THE PLUNGER MOTOR, POWER SUPPLY PWA AND DRIVER PWA WERE REPLACED.

    Additional Manufacturer Narrative · 1

    MULTIPLE ATTEMPTS HAVE BEEN MADE FOR ADDITIONAL INFORMATION REGARDING THE EVENT AND THE DEVICE STATUS; HOWEVER, THERE WAS NO RESPONSE. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A PLUM 360 PUMP HAD A BURNT PWA (PRINTED WIRED ASSEMBLY). THERE WAS UNKNOWN PATIENT INVOLVEMENT AND NO REPORT OF AN ADVERSE EVENT, MEDICAL INTERVENTION AND DELAY IN CRITICAL THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    156946 PLUM 360 DRIVER FRENCH PUMP, INFUSION FRN ICU MEDICAL COSTA RICA LTD.

    Patients

    Seq Age Sex Outcome Treatment
    1