BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRIMARY PLUM SET, 15 MICRON FILTER IN SIGHT CHAMBER, CLAVE SECONDARY PORT, 0.2 M

    MDR report key: 23839922 · Received December 18, 2025

    Report

    Report Number
    9615050-2025-00626
    Event Type
    Malfunction
    Date Received
    December 18, 2025
    Date of Event
    December 10, 2025
    Report Date
    December 18, 2025
    Manufacturer
    ICU MEDICAL COSTA RICA LTD.
    Product Code
    FPA
    PMA / PMN Number
    K142974
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    IT IS UNKNOWN IF THE DEVICE IS AVAILABLE FOR EVALUATION. THE DEVICE HAS BEEN REQUESTED TO BE RETURNED, HOWEVER, IT HAS NOT BEEN RECEIVED. WITHOUT THE RETURNED DEVICE, A PROBABLE CAUSE IS UNABLE TO BE DETERMINED.

    Description of Event or Problem · 0

    AN EMAIL WAS RECEIVED REGARDING PRIMARY PLUM SET, 15 MICRON FILTER IN SIGHT CHAMBER, CLAVE SECONDARY PORT, 0.2 MICRON FILTER, POLYETHYLENE LINED TUBING, SECURE LOCK, 225 CM GENERATED A LEAK DURING PATIENT USE. THE REPORTER STATED THE FOLLOWING:¿ DURING THE USE OF SEVERAL THERANOJET KITS (LEMERPAX), A LEAK WAS OBSERVED IN THE SYSTEM'S VENTED FILTER. THIS FILTER, WHICH NORMALLY EXHAUSTS AIR, LEAKED CONTAMINATED LIQUID, CREATING A SIGNIFICANT RISK OF CONTAMINATION FOR EQUIPMENT AND PERSONNEL. GIVEN THE LONG DECAY PERIOD OF THE RADIONUCLIDE USED, ALL POTENTIALLY EXPOSED EQUIPMENT HAD TO BE QUARANTINED FOR AN EXTENDED PERIOD, SEVERELY DISRUPTING THE UNIT'S OPERATIONS. THIS EVENT OCCURRED TWICE RECENTLY WITH THE SAME BATCH.¿ THE EVENT TOOK PLACE AT THE NUCLEAR MEDICINE. THERE WAS NO PATIENT HARM REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2244541 PRIMARY PLUM SET, 15 MICRON FILTER IN SIGHT CHAMBER, CLAVE SECONDARY PORT, 0.2 M SET, ADMINISTRATION, INTRAVASCULAR FPA ICU MEDICAL COSTA RICA LTD. NI

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown THERANOJET (LEMERPAX), UNK MFR.