BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 21398136 · Received February 18, 2025

    Report

    Report Number
    9615050-2025-00081
    Event Type
    Malfunction
    Date Received
    February 18, 2025
    Date of Event
    October 20, 2024
    Report Date
    September 25, 2025
    Manufacturer
    ICU MEDICAL COSTA RICA LTD.
    Product Code
    FPA
    PMA / PMN Number
    K141789
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    RECEIVED THREE (3) USED PLUM SETS. THIS REFLECTS THE SECOND OF THE THREE. AS RECEIVED, ALL THREE SAMPLES CONTAINED FLUID. SAMPLE WAS OBSERVED TO HAVE HAD THE DRIP CHAMBER REMOVED AND THE CLAVE ON THE SECONDARY PORT HAD A STICK DOWN. UPON FURTHER EXAMINATION, BOTH OF THE OTHER SAMPLES WERE OBSERVED TO HAVE TEARING ON THE FACE OF THE SEALS OF THE CLAVES ON THE SECONDARY PORT. IN AN ATTEMPT TO REPLICATE CLINICAL USE, THE RECEIVED SAMPLES WERE DRAINED OF THE RESIDUAL FLUID RECEIVED BY GRAVITY. THE FLUID WAS SUCCESSFULLY DRAINED FROM ALL THREE SAMPLES. WATER WAS THEN FLUSHED THROUGH SAMPLES 2 AND 3. WATER WAS SUCCESSFULLY PUSHED THROUGH SAMPLE 3 BUT COULD NOT PUSH THROUGH SAMPLE 2. CLAVES WERE DISASSEMBLED AND SPIKES AND SEALS OF ALL SAMPLES WERE OBSERVED TO BE DAMAGED, WITH FLASH OBSERVED ON THE TWO WITH INTACT TIPS. BASED ON OBSERVATIONS THROUGH DECONSTRUCTION, THE COMPLAINT OF DIFFICULTY FLUSHING CAN BE CONFIRMED DUE TO DAMAGES FOUND AT THE SECONDARY PORT. PROBABLE CAUSE IS DUE TO A MOLDING ERROR IN MANUFACTURING. A DEVICE HISTORY REPORT (DHR) LOT AND RELEVANT COMMODITIES WERE REVIEWED, THE FOLLOWING DISCREPANCY WAS IDENTIFIED: EXCEPTION TYPE: NCMR; DOCUMENT ID#: (B)(4); LOT#: 13677270. DISCREPANCY: "DURING VISUAL INSPECTION ON 07/29/2023 ON SHIFT A1 FOR PRESS (B)(4) ITEM R1-3345 (CONNECTOR Y SPIKE, 2 WINDOW), MOLDING QA FOUND CAV E1, Z9 HAS TIP FLASH MEASURING .013-.019 (MAX .010) ON 7/30/2023 A2 SHIFT VISUAL INSPECTOR FOUND THAT E1 AND Z9 WAS GOING INTO GOOD PARTS. SUPPOSE TO BE SCRAPPING. AFTER BRACKETING TOTES 57-138 WAS AFFECTED."

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION/CORRECTED INFORMATION IN THE FOLLOWING FEILDS: D1 - BRAND NAME. D4 - LOT #, MATERIAL#, EXPIRATION DATE, PRIMARY UDI NUMBER. G4 - PMA/510(K) #. H4 - DEVICE MFG DATE.

    Additional Manufacturer Narrative · 0

    FURTHER REVIEW OF THIS NON COMFORANCE/NCMR AND THE INVESTIGATION, IT HAS BEEN NOTED THAT THE COMPONENT WITH THE TIP FLASH IN THIS NCMR IS FOR THE Y-CLAVE AND NOT THE CLAVE CONNECTED TO THE SECONDARY PORT. THEREFORE, THIS NON-CONFORMITY IS NOT RELATED TO THE FAILURE MODE EXPERIENCED BY THE CUSTOMER.

    Description of Event or Problem · 0

    THE EVENT INVOLVED AN UNSPECIFIED PLUM SET WHERE THE CUSTOMER REPORTED THAT IT IS DIFFICULT FLUSHING WITH FORCE. THERE WAS UNKNOWN PATIENT INVOLVEMENT, UNKNOWN DELAY IN THERAPY, NO HARMED AS A RESULT OF THE REPORTED EVENT AND NO INVOLVE DEATH OR SERIOUS DETERIORATION OF A PERSON. THIS IS THE SECOND OF 3 OCCURRENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1179856 PRIMARY PLUM SET, 15 MICRON FILTER IN SIGHT CHAMBER, CLAVE SECONDARY PORT, CLAVE SET, ADMINISTRATION, INTRAVASCULAR FPA ICU MEDICAL COSTA RICA LTD. 13935374

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown