BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    6.5" (17 CM) APPX 1.1 ML, SMALLBORE QUADFUSE EXT SET W/4 MICROCLAVE¿ CLEAR (RED,

    MDR report key: 17870293 · Received October 4, 2023

    Report

    Report Number
    9617594-2023-00794
    Event Type
    Malfunction
    Date Received
    October 4, 2023
    Date of Event
    September 6, 2023
    Report Date
    September 6, 2023
    Manufacturer
    ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.
    Product Code
    FMG
    UDI-DI
    00887709085671
    PMA / PMN Number
    K964435
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    RECIEVED ONE USED. LIST #MC330375, 6.5" (17 CM) APPX 1.1 ML, SMALLBORE QUADFUSE EXT SET W/4 MICROCLAVE¿ CLEAR (RED, PURPLE, TPN RINGS), 0.2 MICRON FILTER, 1.2 MICRON FILTER, 4 CLAMPS, CHECK VALVE, LUER LOCK; LOT #13551095. LIPID SOLUTION RESIDUALS OBSERVED IN USED LIST #MC330375 AND MATING DEVICE OF ONE USED. LIST #UNKNOWN, 0.9% SODIUM CHLORIDE 10ML SYRINGE; LOT #3142761. THE USED MC330375 EXTENSION SET RETURNED HAD VISIBLE LIPIDS WITHIN THE FLUID PATH AND WITHIN THE INLINE FILTERS. NO OTHER ANOMALIES OR DAMAGE WERE OBSERVED. THE MC330375 EXTENSION SET WAS PRIMED AND PRESSURE LEAK TESTED. BAG 2 FILTER LINE A: PRIMED WITHOUT DIFFICULTY. NO LEAKAGE AT ANY LOCATION ALONG THE LINE. BAG 2 FILTER LINE B (TPN): PRIMED WITHOUT DIFFICULTY. NO LEAKAGE AT ANY LOCATION ALONG THE LINE. THERE WAS LEAKAGE OBSERVED AT THE HARD TO HARD BOND BETWEEN THE MALE LUER OF THE TRIFUSE ADAPTER AND THE FEMALE LUER OF THE CHECK VALVE. CHANNEL LEAK. THE PROBABLE CAUSE OF THE LEAK IS TYPICAL OF INSUFFICIENT SOLVENT COVERAGE DURING MANUAL ASSEMBLY. THE LOT HISTORY WAS REVIEWED AND NO NONCONFORMITIES WERE IDENTIFIED THAT MAY HAVE CONTRIBUTED TO THE REPORTED COMPLAINT.

    Description of Event or Problem · 0

    THE EVENT INVOLVED A 6.5" (17 CM) APPX 1.1 ML, SMALLBORE QUADFUSE EXT SET W/4 MICROCLAVE¿ CLEAR (RED, PURPLE, TPN RINGS), 0.2 MICRON FILTER, 1.2 MICRON FILTER, 4 CLAMPS, CHECK VALVE, LUER LOCK WHERE IT WAS REPORTED THROUGH INVESTIGATION, THAT ONE SAMPLE WAS CONFIRMED TO HAVE A BONDING CHANNEL LEAK. THE PROBABLE CAUSE OF THE LEAK IS TYPICAL OF INSUFFICIENT SOLVENT COVERAGE DURING MANUAL ASSEMBLY. ACCORDING TO THE ORIGINAL COMPLAINT PROVIDED BY THE CUSTOMER THE EVENT WAS NOT DETECTED PRIOR TO DIRECT PATIENT USE. THERE WAS NO BLOOD LOSS, NO UNPROTECTED CHEMO EXPOSURE, AND NO MEDICAL/SURGICAL INTERVENTION REQUIRED. THERE WAS PATIENT INVOLVEMENT, NO ADVERSE OPERATOR CONSEQUENCES AND NO DELAY IN CRITICAL THERAPY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1381423 6.5" (17 CM) APPX 1.1 ML, SMALLBORE QUADFUSE EXT SET W/4 MICROCLAVE¿ CLEAR (RED, STOPCOCK, I.V. SET FMG ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 13551095 00887709085671

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown LIPIDS, UNK MFR.