BEUDAMED
    FDA Adverse Event Death Summary report: N

    ARROW CVC SET: 3-LUMEN 12 FR X 16 CM

    MDR report key: 17640914 · Received August 29, 2023

    Report

    Report Number
    3006425876-2023-00811
    Event Type
    Death
    Date Received
    August 29, 2023
    Date of Event
    July 29, 2023
    Report Date
    August 3, 2023
    Manufacturer
    ARROW INTERNATIONAL LLC
    Product Code
    DQY
    UDI-DI
    00801902102119
    PMA / PMN Number
    K862056
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4).

    Additional Manufacturer Narrative · 0

    QN#(B)(4). THE ACTUAL DEVICE WAS NOT RETURNED; HOWEVER, THE CUSTOMER PROVIDED TWO PHOTOS FOR ANALYSIS. THE COMPLAINT OF EXTENSION LINE SEPARATED/TORN DURING USE WAS ABLE TO BE CONFIRMED BY THE PHOTOS. BOTH PHOTOS REVEALED THAT THE DISTAL EXTENSION LINE OF THE CATHETER WAS SEPARATED AS THE EXTENSION LINE HUB WAS MISSING FROM THE DEVICE. THE SEPARATED HUB IS NOT VISIBLE IN THE PHOTOS, THEREFORE , IT CANNOT BE CONFIRMED WHERE ON THE EXTENSION LINE THE SEPARATION OCCURRED. A COMPLETE VISUAL INSPECTION COULD NOT BE PERFORMED AS NO SAMPLE WAS RETURNED FOR ANALYSIS. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED, AND NO RELEVANT FINDINGS WERE IDENTIFIED. THE INSTRUCTIONS FOR USE (IFU) PROVIDED WITH THIS KIT WARNS THE USER, "DO NOT SECURE, STAPLE AND/OR SUTURE DIRECTLY TO OUTSIDE DIAMETER OF CATHETER BODY OR EXTENSION LINES TO REDUCE RISK OF CUTTING OR DAMAGING THE CATHETER OR IMPEDING CATHETER FLOW. SECURE ONLY AT INDICATED STABILIZATION LOCATIONS. AIR EMBOLISM CAN OCCUR IF AIR IS ALLOWED TO ENTER A CENTRAL VENOUS ACCESS DEVICE OR VEIN. DO NOT LEAVE OPEN NEEDLES OR UNCAPPED, UNCLAMPED CATHETERS IN CENTRAL VENOUS PUNCTURE SITE. USE ONLY SECURELY TIGHTENED LUER-LOCK CONNECTIONS WITH ANY CENTRAL VENOUS ACCESS DEVICE TO GUARD AGAINST INADVERTENT DISCONNECTION." THE CUSTOMER REPORT OF EXTENSION LINE SEPARATED/TORN DURING USE WAS CONFIRMED BY VISUAL INSPECTION OF THE CUSTOMER SUPPLIED PHOTOS. BOTH PHOTOS REVEALED THAT THE DISTAL EXTENSION LINE OF THE CATHETER WAS SEPARATED AS THE EXTENSION LINE HUB WAS MISSING FROM THE DEVICE. HOWEVER, FULL COMPLAINT VERIFICATION TESTING COULD NOT BE PERFORMED AS NO SAMPLE WAS RETURNED FOR ANALYSIS. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED, AND NO RELEVANT FINDINGS WERE IDENTIFIED. WITHOUT THE DEVICE TO EVALUATE, THE PROBABLE CAUSE COULD NOT BE DETERMINED FROM THE AVAILABLE INFORMATION. TELEFLEX WILL CONTINUE TO MONITOR AND TREND FOR REPORTS OF THIS NATURE.

    Description of Event or Problem · 0

    IT WAS REPORTED "INCIDENT OCCURRED ON (B)(6) 2023. UNDER THE EFFECT OF TRACTION (PATIENT HAVING STOOD UP), THE INFUSION LINE OF THE CATHETER BROKE. (CATHETER INSERTED ON 28 JULY). THE DOCTOR WAS CALLED BY NURSES. DOCTOR INSTRUCTED TO IMMEDIATELY REMOVE THE CATHETER. WHEN THE NURSES ARRIVED, PATIENT WAS IN RESPIRATORY CARDIAC ARREST. CARDIOPULMONARY RESUSCITATION STARTED BY THE PARAMEDICAL TEAM AND CALL FOR RESUSCITATION. PATIENT DECEASED." IT WAS REPORTED BY THE HOSPITAL THAT THE PATIENT HAD BEEN IN FOLLOW-UP CARE AND REHABILITATION DEPARTMENT FOLLOWING A RECENT STROKE. "THE PARAMEDICAL TEAM NOTICED THAT THE CATHETER WAS CUT, SO THEY GOT THE DOCTOR ON CALL, WHO GAVE INSTRUCTIONS TO REMOVE THE DEVICE. PATIENT WAS IN CARDIAC ARREST WHEN THEY CAME BACK TO THE ROOM." THE TIME INTERVAL FROM WHEN THE ISSUE WAS DETECTED TO DEATH WAS 5 MINUTES. THE CAUSE OF DEATH IS REPORTED AS "UNEXPECTED CARDIORESPIRATORY ARREST". AN AUTOPSY WAS NOT PERFORMED.

    Description of Event or Problem · 0

    IT WAS REPORTED "INCIDENT OCCURRED ON (B)(6) 2023. UNDER THE EFFECT OF TRACTION (PATIENT HAVING STOOD UP), THE INFUSION LINE OF THE CATHETER BROKE. (CATHETER INSERTED ON (B)(6)). THE DOCTOR WAS CALLED BY NURSES. DOCTOR INSTRUCTED TO IMMEDIATELY REMOVE THE CATHETER. WHEN THE NURSES ARRIVED, PATIENT WAS IN RESPIRATORY CARDIAC ARREST. CARDIOPULMONARY RESUSCITATION STARTED BY THE PARAMEDICAL TEAM AND CALL FOR RESUSCITATION. PATIENT DECEASED." IT WAS REPORTED BY THE HOSPITAL THAT THE PATIENT HAD BEEN IN FOLLOW-UP CARE AND REHABILITATION DEPARTMENT FOLLOWING A RECENT STROKE. "THE PARAMEDICAL TEAM NOTICED THAT THE CATHETER WAS CUT, SO THEY GOT THE DOCTOR ON CALL, WHO GAVE INSTRUCTIONS TO REMOVE THE DEVICE. PATIENT WAS IN CARDIAC ARREST WHEN THEY CAME BACK TO THE ROOM." THE TIME INTERVAL FROM WHEN THE ISSUE WAS DETECTED TO DEATH WAS 5 MINUTES. THE CAUSE OF DEATH IS REPORTED AS "UNEXPECTED CARDIORESPIRATORY ARREST". AN AUTOPSY WAS NOT PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    958938 ARROW CVC SET: 3-LUMEN 12 FR X 16 CM CATHETER PERCUTANEOUS DQY ARROW INTERNATIONAL LLC IPN919472 71F22A0743 00801902102119

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Unknown Death| R NOT REPORTED| NOT REPORTED