BEUDAMED
    FDA Adverse Event Death Summary report: N

    PERM-CATHETER

    MDR report key: 8045964 · Received November 2, 2018

    Report

    Report Number
    8045964
    Event Type
    Death
    Date Received
    November 2, 2018
    Date of Event
    October 23, 2018
    Report Date
    November 1, 2018
    Manufacturer
    COVIDIEN
    Product Code
    KNZ
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    NC, US
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 1

    PT HAS PERM-CATHETER VASCATH PLACED IN OPERATING ROOM ON (B)(6) 2018 WITHOUT COMPLICATIONS. PT RETURNED TO FLOOR. DURING THE EVENING HOURS, THE PT WAS FOUND PULSELESS. CATHETER TORN APART FOUND LAYING ON BEDSIDE TABLE. RESUSCITATION EFFORTS FAILED TO REVIVE PT. LEFT INTERNAL JUGULAR VEIN DOUBLE LUMEN PERMCATH DIALYSIS CATHETER PLACEMENT WITH ULTRASOUND AND FLUOROSCOPIC GUIDANCE. A (B)(6) WITH RENAL FAILURE DUE TO IGA NEPHROPATHY REQUIRING HEMODIALYSIS. THE CATHETER WAS SECURED TO THE SKIN OF THE EXIT SITE WITH 3-0 PDS SUTURE. MASTISOL AND STERI-STRIPS WERE APPLIED. A TEGADERM DRESSING WAS APPLIED TO THE CATHETER EXIT SITE. PROCEDURE COMPLETED BY 1615 ON (B)(6) 2018. NO EVIDENCE OF HEMO OR PNEUMOTHORAX. PT RETURNED TO ROOM. FAMILY OF THE PT LEFT PT ROOM DURING THE EVENING HOURS. NURSING CHECKS BEING PERFORMED AT 2330 AND PT DISCOVERED TO BE PALE AND UNRESPONSIVE. THE PROXIMAL END OF THE CATHETER WITH THE ARTERIAL AND VENOUS LINES WAS LYING ON THE BEDSIDE TABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    871650 PERM-CATHETER CENTRAL LINE KNZ COVIDIEN 8817749001 UNK

    Patients

    Seq Age Sex Outcome Treatment
    0 17 YR Death