BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    14" EXT SET W/0.2 MICRON FILTER, CLAVE¿ CLEAR, CLAMP, ROTATING LUER

    MDR report key: 22061952 · Received May 21, 2025

    Report

    Report Number
    9617594-2025-01072
    Event Type
    Malfunction
    Date Received
    May 21, 2025
    Date of Event
    April 10, 2025
    Report Date
    June 24, 2025
    Manufacturer
    ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.
    Product Code
    FMG
    UDI-DI
    00887709039391
    PMA / PMN Number
    K964435
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE HAS BEEN RECEIVED FOR EVALUATION. INVESTIGATION IS PENDING. ADDITIONAL REPORTER: (B)(6).

    Additional Manufacturer Narrative · 0

    ONE USED. LIST #MC9013, 14" EXT SET W/0.2 MICRON FILTER, CLAVE¿ CLEAR, CLAMP, ROTATING LUER WAS RETURNED FOR EVALUATION. AS RECEIVED AN UNKNOWN SOLUTION RESIDUAL INSIDE WAS FOUND. THE SAMPLE WAS TESTED AND LEAKAGE FROM THE INTLET FILTER VENT AND A SMALL AIR BUBBLE INSIDE THE FILTER WAS NOTED. NO ADDITIONAL DAMAGE OR ANOMALIES WERE OBSERVED. COMPLAINT OF LEAKS CAN BE CONFIRMED. THE PROBABLE CAUSE IS TYPICAL DUE TO A TEMPORARY OR COMPLETE LOSS OF HYDROPHOBIC PROPERTIES OF THE FILTER VENT MATERIAL DUE TO AN INFUSATE INTERACTION DURING USE. THE LOT HISTORY WAS REVIEWED, NO NONCONFORMITIES WERE IDENTIFIED THAT MAY HAVE CONTRIBUTED TO THE REPORTED COMPLAINT.

    Description of Event or Problem · 0

    THE EVENT INVOLVED A 14" EXT SET W/0.2 MICRON FILTER, CLAVE¿ CLEAR, CLAMP, ROTATING LUER WHERE IT WAS REPORTED THE REGISTERED NURSE (RN) WENT TO HOOK PATIENT UP TO IV LINE WITH FILTER, PATIENT NOTICED A LARGE AIR BUBBLE COMING FROM FILTER. THE IV LINE WAS DISCONNECTED THREE TIMES TO REMOVE AIR AND FILTER KEPT PRODUCING AIR BUBBLES. DUE TO THE PATIENT HAVING A HISTORY OF HEREDITARY HEMORRHAGIC TELANGIECTASIA (HHT), IT IS PROTOCOL FOR INFUSIONS TO HAVE A FILTER PUT ON IV SET TO PREVENT AIR FROM ENTERING BLOOD STREAM. THERE WAS PATIENT INVOLVEMENT AND A DELAY IN THERAPY. NO HARM WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    59974 14" EXT SET W/0.2 MICRON FILTER, CLAVE¿ CLEAR, CLAMP, ROTATING LUER STOPCOCK, I.V. SET FMG ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 13937964 00887709039391

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female