BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    30 CM (12") ARBRE UNIVERSEL AMBRE AVEC 2 ACCES LUER AVEC VALVE AR ET BOUCHON

    MDR report key: 19389041 · Received May 23, 2024

    Report

    Report Number
    9617594-2024-00651
    Event Type
    Malfunction
    Date Received
    May 23, 2024
    Date of Event
    April 23, 2024
    Report Date
    August 28, 2024
    Manufacturer
    ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.
    Product Code
    FMG
    UDI-DI
    00840619054250
    PMA / PMN Number
    UNKNOWN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHARMACIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ALTHOUGH THE DEVICE WAS REQUESTED TO BE RETURNED FOR EVALUATION, IT HAS NOT BEEN RECEIVED. WITHOUT THE RETURNED DEVICE, A PROBABLE CAUSE IS UNABLE TO BE DETERMINED.

    Additional Manufacturer Narrative · 0

    RECEIVED ONE (1) USED. LIST #UNKNOWN, FRESENIUS KABI G5% GLUCOSE FRESENIUS 5% FREEFLEX 250 ML INTRAVENOUS BAG; LOT #13SKF181. ONE (1) USED. LIST #011-H3248, 30 CM (12") ARBRE UNIVERSEL AMBRE AVEC 2 ACCES LUER AVEC VALVE AR ET BOUCHON; LOT #4389286. ONE (1) USED. LIST #UNKNOWN, EXTENSION TUBING WITH DRIP CHAMBER; LOT #UNKNOWN. ONE (1) USED. LIST #UNKNOWN, FRESENIUS KABI CHLORURE DE SODIUM FRESENIUS 0,9% FREEFLEX 100 ML INTRAVENOUS BAG; LOT #13TBR151. AND ONE (1) NEW. LIST #011-H3248, 30 CM (12") ARBRE UNIVERSEL AMBRE AVEC 2 ACCESS LUER AVEC VALVE AR ET BOUCHON; LOT #4389286. NOTED THAT ONE BACK CHECK VALVE WAS DISCONNECTED FROM THE TUBING SET. THE PARTS WERE OBSERVED THROUGH UV LIGHT AND INSUFFICIENT PRESENCE OF SOLVENT ON CHECK VALVE AND TRIFURCATE WAS OBSERVED. NO DAMAGE OR EXCESSIVE FORCE BEING APPLIED WAS OBSERVED. NO OTHER DEFECTS OR ANOMALIES WERE NOTED. EXAMINED ONE (1) NEW TUBING SET, NO DEFECTS OR ANOMALIES WERE NOTED. THE REST OF THE CHECK VALVES WERE BOND TESTED AND MET SPECIFICATIONS. COMPLAINT OF A LEAK AT THE CONNECTION VALVE WHEN CONNECTING A CHEMOTHERAPY BAG TO ONE OF THE TWO ACCESS LUERS CAN BE CONFIRMED BASED ON THE PHYSICAL SAMPLE EVALUATION. THE PROBABLE CAUSE WAS DUE TO A BONDING ERROR DURING MANUAL PROCESS ASSEMBLY IN ENSENADA. THE LOT HISTORY WAS REVIEWED, NO NONCONFORMITIES WERE IDENTIFIED THAT MAY HAVE CONTRIBUTED TO THE REPORTED COMPLAINT

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A 30 CM (12") ARBRE UNIVERSEL AMBRE AVEC 2 ACCES LUER AVEC VALVE AR ET BOUCHON, GENERATED A LEAK DURING PATIENT USE. THE FOLLOWING ISSUE WAS REPORTED BY THE CUSTOMER: LEAK AT THE CONNECTION VALVE WHEN CONNECTING A CHEMOTHERAPY BAG TO ONE OF THE TWO ACCESS LUERS. CLINICAL CONSEQUENCES: LOSS OF PRODUCT (APPROXIMATELY 25ML) BEFORE IDENTIFYING THE PROBLEM AND CLAMPING. PERSONNEL AND PATIENT EXPOSED (DOCETAXEL). ACTIONS TAKEN: CHANGED THE CHEMOTHERAPY LINE, RECONNECTING THE BAG TO THE NEW LINE.¿ THE STATUS OF THE PRODUCT AT THE TIME OF THE EVENT IS WHEN CONNECTING A CHEMOTHERAPY BAG TO THE ACCESS LUER. THE PRODUCT IS AVAILABLE FOR EVALUATION. THERE WAS NO PATIENT HARM REPORTED. THE HEALTH CONDITION OF THE PATIENT IS STABLE, THERE WAS NO BLOOD LOSS, THE PATIENT RECOVERED, THEIR HOSPITAL STAY WAS NOT EXTENDED DUE TO THE INCIDENT. AN ADDITIONAL MEDICAL INTERVENTION WAS REQUIRED, THERE WAS A DELAY OF 1 HOUR IN THERAPY DUE TO THE DOCTOR'S CALL TO THE PHARMACY FOR THE PLAN OF ACTION. THERE WERE NO PHYSICAL DEFECTS SEEN ON THE DEVICE BEFORE USE AND THE LEAK WAS CLEANED ACCORDING TO THE FACILITY'S PROTOCOL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    656651 30 CM (12") ARBRE UNIVERSEL AMBRE AVEC 2 ACCES LUER AVEC VALVE AR ET BOUCHON BASIC INTRAVENOUS ADMINISTRATION SET, NONINVASIVE FMG ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 4389286 00840619054250

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Male DOCETAXEL, UNK MFR.