BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRIMARY PLUM SET, 15 MICRON FILTER IN SIGHT CHAMBER, CLAVE SECONDARY PORT, CLAVE

    MDR report key: 18162076 · Received November 17, 2023

    Report

    Report Number
    9615050-2023-00647
    Event Type
    Malfunction
    Date Received
    November 17, 2023
    Date of Event
    September 12, 2023
    Report Date
    November 17, 2023
    Manufacturer
    ICU MEDICAL COSTA RICA LTD.
    Product Code
    FPA
    UDI-DI
    10887709100128
    PMA / PMN Number
    K141789
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE COMPLAINT OF AIR IN LINE ON THE 140019291 COULD NOT BE CONFIRMED BY INVESTIGATION. NO PRODUCT SAMPLES, PICTURES, OR VIDEOS WERE RECEIVED FOR INVESTIGATION. WITHOUT THE RETURN OF THE USED SAMPLE A COMPREHENSIVE FAILURE INVESTIGATION CANNOT BE PERFORMED AND A CAUSE CANNOT BE DETERMINED. THE DEVICE HISTORY REPORT (DHR) FOR LOT 7884751 WAS REVIEWED AND NO NON CONFORMITIES WERE FOUND THAT WOULD HAVE LED TO THE REPORTED COMPLAINT.

    Description of Event or Problem · 0

    THE EVENT INVOLVED A PRIMARY PLUM SET, 15 MICRON FILTER IN SIGHT CHAMBER, CLAVE SECONDARY PORT, CLAVE Y-SITE, SECURE LOCK, 272 CM WHERE THE CUSTOMER REPORTED AN EXCESSIVE AIR IN LINE DISTAL TO CASSETTE IN PLUM INFUSION PUMP SET. THE PUMP ALARMED EVENTUALLY IN MOST OCCASIONS. THE NURSE SAW AIR DISTAL TO PUMP, PROXIMAL TO PATIENT. THERE WAS PATIENT INVOLVEMENT AND NO PATIENT HARM IN THE REPORTED EVENT. THIS IS THE SECOND OF TWO REPORTED EVENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1670029 PRIMARY PLUM SET, 15 MICRON FILTER IN SIGHT CHAMBER, CLAVE SECONDARY PORT, CLAVE SET, ADMINISTRATION, INTRAVASCULAR FPA ICU MEDICAL COSTA RICA LTD. 7884751 10887709100128

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown PLUM INFUSION PUMP, ICU MED