BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    12" (30 CM) EXT SET W/1.2 MICRON FILTER, CLAMP, ROTATING LUER

    MDR report key: 18161045 · Received November 17, 2023

    Report

    Report Number
    9617594-2023-00994
    Event Type
    Malfunction
    Date Received
    November 17, 2023
    Date of Event
    October 15, 2023
    Report Date
    January 4, 2024
    Manufacturer
    ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.
    Product Code
    FMG
    PMA / PMN Number
    K964435
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    RECEIVED ONE USED. LIST #B1115, 12" (30 CM) EXT SET W/1.2 MICRON FILTER, CLAMP, ROTATING LUER; LOT #UNKNOWN. ONE USED. LIST #UNKNOWN, 10ML SYRINGE; LOT #UNKNOWN. ONE USED. MANUFACTURING UNKNOWN, EXTENSION SET W/ PIERCING PIN; LOT #UNKNOWN. ONE USED. LIST #UNKNOWN, SMOFLIPID 100ML BAG; LOT #10RI4362. IT WAS NOTED THAT THE B1115 EXTENSION SET HAD THE INLET FILTER VENT WETTED OUT WHEN RECEIVED. DURING FUNCTIONAL TESTING LEAKAGE WAS CONFIRMED AT THE INLET FILTER VENT. THE PROBABLE CAUSE OF THE OBSERVED LEAK IS TEMPORARY OR PERMANENT LOSS OF THE HYDROPHOBIC PROPERTIES OF THE FILTER VENT MATERIAL DUE TO INFUSATE INTERACTION. A DEVICE HISTORY REVIEW (DHR) LOT # REVIEW COULD NOT BE CONDUCTED BECAUSE NO LOT NUMBER(S) WAS/WERE IDENTIFIED.

    Additional Manufacturer Narrative · 0

    THE DEVICE HAS BEEN RECEIVED FOR EVALUATION; INVESTIGATION IS PENDING.

    Description of Event or Problem · 0

    THE EVENT INVOLVED A 12" (30 CM) EXT SET W/1.2 MICRON FILTER, CLAMP, ROTATING LUER WHERE IT WAS REPORTED THERE WAS A LEAKING EXT SET WHILE ON PATIENT INFUSING LIPID MEDICATION. THE LEAKING OCCURRED AROUND THE FILTER. THERE WAS NO OBVIOUS DEFECT NOTED ON THE TUBING SET LIKE CRACKS, OR BREAKS. THERE WAS PATIENT INVOLVEMENT AND A DELAY IN THERAPY DUE TO TUBING NEEDED TO BE CHANGED, HOWEVER NO HARM WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1668974 12" (30 CM) EXT SET W/1.2 MICRON FILTER, CLAMP, ROTATING LUER STOPCOCK, I.V. SET FMG ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown LIPIDS, UNK MFR