BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    31" (79 CM) APPX 3.3 ML, EXT SET W/CLAMP, ROTATING LUER

    MDR report key: 17030205 · Received May 31, 2023

    Report

    Report Number
    9617594-2023-00219
    Event Type
    Malfunction
    Date Received
    May 31, 2023
    Date of Event
    March 6, 2023
    Report Date
    March 29, 2023
    Manufacturer
    ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.
    Product Code
    FMG
    UDI-DI
    00887709000599
    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

    THE COMPLAINT OF LEAKS CAN NOT BE CONFIRMED BASED ON THE THE VIDEO PROVIDED BY CUSTOMER BECAUSE THE LEAKS APPEAR TO BE COMING FROM THE NON-ICU PRODUCT AND PHYSICAL SAMPLE WAS NO RECEIVED FOR INVESTIGATION. WITHOUT THE RETURN OF THE USED SAMPLE A COMPREHENSIVE FAILURE INVESTIGATION CANNOT BE PERFORMED AND A CAUSE CANNOT BE DETERMINED. THE DEVICE HISTORY REPORT (DHR) FOR LOT 6032751 WAS REVIEWED AND NO NON CONFORMITIES WERE FOUND THAT WOULD HAVE LED TO THE REPORTED COMPLAINT.

    Description of Event or Problem · 0

    THE DEVICE INVOLVED IS A 31" (79 CM) APPX 3.3 ML, EXT SET W/CLAMP, ROTATING LUER WHERE IT WAS REPORTED THAT A GENERAL ANESTHESIA WAS BEING DELIVERED USING INTRAVENOUS MEDICATION VIA A SYRINGE AND INFUSION SET IN A SYRINGE PUMP. THE INFUSION SET DEVELOPED A LEAK, RESULTING IN ANESTHETIC SOLUTION BEING PUMPED OUT OF THE SYSTEM AND ONTO THE FLOOR AND NOT INTO THE PATIENT. THIS WAS NOT NOTICED. INCIDENT IMPACT IS SUDDEN, UNCONTROLLED PARTIAL EMERGENCE FROM ANESTHESIA IN THE MIDDLE OF A NEUROSURGICAL PROCEDURE. THERAPY WAS RESUMED. THERE WAS NO LONG-TERM PATIENT IMPACT REPORTED. THERE WAS PATIENT INVOLVEMENT BUT NO PATIENT HARM. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1030559 31" (79 CM) APPX 3.3 ML, EXT SET W/CLAMP, ROTATING LUER STOPCOCK, I.V. SET FMG ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. B1154 6032751 00887709000599

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown SYRINGE, MFR UNK.| UNSPECIFIED GENERAL ANESTHESIA, MFR UNK.