BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    60" (152 CM) APPX 1.0 ML, SMALLBORE EXT SET W/MICROCLAVE® CLEAR, CLAMP, LUER LOC

    MDR report key: 19874303 · Received July 31, 2024

    Report

    Report Number
    9617594-2024-00977
    Event Type
    Malfunction
    Date Received
    July 31, 2024
    Date of Event
    June 18, 2024
    Report Date
    July 31, 2024
    Manufacturer
    ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.
    Product Code
    FMG
    PMA / PMN Number
    K964435
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ONLY DI PROVIDED AS LOT NUMBER IS UNKNOWN. THE DEVICE WAS NOT RETURNED FOR EVALUATION. WITHOUT THE RETURN OF THE SAMPLE A COMPREHENSIVE FAILURE INVESTIGATION CANNOT BE PERFORMED, AND A CAUSE CANNOT BE DETERMINED.

    Description of Event or Problem · 0

    THE EVENT INVOLVED A 60" (152 CM) APPX 1.0 ML, SMALLBORE EXT SET W/MICROCLAVE® CLEAR, CLAMP, LUER LOCK WHERE IT WAS REPORTED THERE WAS AN INCIDENT FOR ITEM BOPMC33932 ICU MEDICAL MICROBORE TUBING AND ITEM IME10011865 BD PAL FILTER WHEN USED TOGETHER. PATIENT HAD MILRINONE AND EPINEPHRINE RUNNING THROUGH RED LUMEN ON LADLPICC (PERIPHERALLY INSERTED CENTRAL CATHETER). PATIENT¿S OXYGEN (O2) STARTED TO DECREASE BELOW GOAL AND R. FLANK NEAR-INFRARED SPECTROSCOPY (NIRS) WAS <40. PROVIDER NOTIFIED, AFTER THIS REGISTERED NURSE (RN) INCREASED O2 REQUIREMENTS WITH NO CHANGES IN PATIENT¿S VITAL SIGNS. RN LOOKED AT INTRAVENOUS (IV) TUBING AND NOTICED THAT THE MICRO-FILTERS LEAKING. THIS RN CALLED RESOURCE AND SAQ, AND PROVIDER CAME TO BEDSIDE. MICRO-FILTERS WERE REMOVED, AND NEW ONES WERE PLACED. THERE WAS PATIENT INVOLVEMENT, AND NO PATIENT HARM REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1216873 60" (152 CM) APPX 1.0 ML, SMALLBORE EXT SET W/MICROCLAVE® CLEAR, CLAMP, LUER LOC STOPCOCK, I.V. SET FMG ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention BD PAL FILTER LIST 10011865 LOT (10)24029420| EPINEPHRINE, UNK MFR| MILRINONE, UNK MFR| PERIPHERALLY INSERTED CENTRAL CATHETER, UNK MFR