BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRIMARY PLUM SET, 1.2 MICRON FILTER, CLAVE Y-SITE, SECURE LOCK, 104 INCH

    MDR report key: 23416539 · Received October 29, 2025

    Report

    Report Number
    9615050-2025-00502
    Event Type
    Malfunction
    Date Received
    October 29, 2025
    Date of Event
    September 27, 2025
    Report Date
    November 27, 2025
    Manufacturer
    ICU MEDICAL COSTA RICA LTD.
    Product Code
    FPA
    UDI-DI
    10887787005407
    PMA / PMN Number
    K141789
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED EVENT COULD NOT BE REPLICATED OR CONFIRMED AS NO PRODUCT SAMPLES, PICTURES (OR) VIDEOS WERE RETURNED. THE LOT HISTORY WAS REVIEWED AND NO NONCONFORMITIES WERE IDENTIFIED THAT MAY HAVE CONTRIBUTED TO THE REPORTED COMPLAINT. THE PROBABLE ROOT CAUSE OF THE ISSUE WAS UNKNOWN. UPDATED INFORMATION CAN BE FOUND IN D9. CORRECTED INFORMATION CAN BE FOUND IN B5.

    Additional Manufacturer Narrative · 0

    IT IS UNKNOWN IF THE DEVICE IS AVAILABLE FOR EVALUATION. THE DEVICE HAS BEEN REQUESTED TO BE RETURNED MULTIPLE TIMES, HOWEVER, IT HAS NOT YET BEEN RECEIVED. THE COMPLAINT INVESTIGATION IS PENDING AT THIS TIME.

    Description of Event or Problem · 0

    THE REPORTED EVENT OF PERIPHERAL PARENTERAL NUTRITION (PPN) LEAKING AT THE FILTER RESULTING IN PPN HAVING TO BE STOPPED HAD TWO REPORTED OCCURRENCES. THIS REPORT CAPTURES TWO SEPARATE OCCURRENCES INVOLVING THE SAME DEVICE MODEL. NO ADDITIONAL IDENTIFYING INFORMATION WAS AVAILABLE FOR ANY OF THE DEVICES.

    Description of Event or Problem · 0

    A PRIMARY PLUM SET, 1.2 MICRON FILTER, CLAVE Y-SITE, SECURE LOCK, 104 INCH REPORTEDLY LEAKED PPN (PERIPHERAL PARENTERAL NUTRITION) AT THE DEVICE'S FILTER. THIS CAUSED THE PATIENT'S PPN INFUSION TO STOP. THERE WAS NO REPORT OF ANY HUMAN HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    216310 PRIMARY PLUM SET, 1.2 MICRON FILTER, CLAVE Y-SITE, SECURE LOCK, 104 INCH SET, ADMINISTRATION, INTRAVASCULAR FPA ICU MEDICAL COSTA RICA LTD. 14299920 10887787005407

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown PPN (PERIPHERAL PARENTERAL NUTRITION), MFR UNK