BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9" SMALLBORE EXT SET W/CLAVE®, CLAMPS, ROTATING LUER

    MDR report key: 8487198 · Received April 5, 2019

    Report

    Report Number
    9617594-2019-00107
    Event Type
    Malfunction
    Date Received
    April 5, 2019
    Date of Event
    January 1, 2019
    Report Date
    March 11, 2019
    Manufacturer
    ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.
    Product Code
    FMG
    UDI-DI
    00887709036512
    PMA / PMN Number
    K964435
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    ONE (1) USED K181-001 9" (23 CM) SMALLBORE EXT SET W/CLAVE®, CLAMPS, ROTATING LUER, NON-DEHP TUBING WAS RECEIVED FOR EVALUATION ON APRIL 15, 2019. THE SINGLE USED K181-001 EXTENSION SET WITH Y-CLAVE WAS RETURNED WITH THE SILICONE SEAL PROTRUDING FROM THE Y-CALVE BODY. SUBSEQUENT PRESSURE LEAK TESTING REVEALED THAT THE SYSTEM DID NOT LEAK AT SPECIFICATION PRESSURE. THE PROBABLE CAUSE OF THE SILICONE SEAL PROTRUSION IS EXCESSIVE BACK PRESSURE DURING USE. THE DFU STATES: FOR SETS EQUIPPED WITH MICROCLAVE-Y SITE: PRIOR TO PRESSURIZING, ACTIVATE THE SLIDE CLAMP AND GIVE THE PRESSURE INFUSION THROUGH THE MICROCLAVE Y-SITE. A DHR LOT# 3707855 AND RELEVANT COMMODITIES WERE REVIEWED AND NO NON-CONFORMANCES WERE FOUND THAT WOULD HAVE CONTRIBUTED TO THE REPORTED COMPLAINT.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION RECEIVED APRIL 8, 2019: THE CUSTOMER STATED THEIR TYPICAL PRACTICE WOULD BE THE EXTENSION SET IS ATTACHED DIRECTLY TO A INTRAVENOUS (IV) CATHETER FOLLOWED BY THE DEVICE AND THE IV LINE. CURRENT PRACTICE WOULD BE TO CHANGE THE IV SET UP EVERY 96 HOURS OR AS NEEDED. THE CUSTOMER WAS UNABLE TO DETERMINE WHEN THE COMPLETE LINES WERE CHANGED FOR THIS EVENT.

    Additional Manufacturer Narrative · 1

    THE DEVICE IS AVAILABLE FOR EVALUATION. IT IS YET TO BE RECEIVED.

    Description of Event or Problem · 1

    THE EVENT OCCURRED ON AN UNKNOWN DATE IN (B)(6) 2019 AND INVOLVED A CUSTOMER REPORT OF AN EXTENSION SET THAT HAD THE FLAT SILICONE PIECE IN THE CENTER OF THE CLAVE POPPING OUT. IT WAS DISCOVERED WHEN THE UNSPECIFIED PUMP WAS ALARMING WITH HIGH PRESSURE LIMIT REACHED. THE CUSTOMER REPORTED THE LINES ARE CHANGED DAILY AFTER BEING PRIMED UNDER A LAMINAR FLOW HOOD. THERE WAS PATIENT INVOLVEMENT. THE CENTRAL LINE WAS UNABLE TO BE SALVAGED AND WAS CHANGED DUE TO A CONCERN FOR STERILITY. THERE WAS A DELAY IN CRITICAL THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    282031 9" SMALLBORE EXT SET W/CLAVE®, CLAMPS, ROTATING LUER STOPCOCK, I.V. SET FMG ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 3707855 00887709036512

    Patients

    Seq Age Sex Outcome Treatment
    1