BEUDAMED
    FDA Adverse Event Injury Summary report: N

    *

    MDR report key: 342991 · Received July 20, 2001

    Report

    Report Number
    342991
    Event Type
    Injury
    Date Received
    July 20, 2001
    Date of Event
    June 12, 2001
    Report Date
    July 12, 2001
    Manufacturer
    SMITHS INDUSTRIES MEDICAL SYSTEMS, SIMS DELTEC INC
    Product Code
    LFJ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE PT WAS ADMITTED IN 06/2001 VIA THE EMERGENCY DEPARTMENT WITH AN "OCCLUDED CATHETER". THE PT HAD BEEN UNABLE TO DIALYZE DUE TO A LEAK IN PT'S TESIO CATHETER WHICH WAS IN THE RIGHT SUBCLAVIAN. THE PT WAS FOUND TO HAVE A CRACK AT THE SKIN LEVEL. PT WAS ADMITTED TO HAVE IT REPAIRED OR POSSIBLY EXCHANGED. THE PT WAS TAKEN TO THE INTERVENTIONAL RADIOLOGY DEPARTMENT WHERE IT WAS FOUND THAT THE CATHETER WAS BRITTLE AND WOULD BREAK WITH TENSION, THEREFORE, THE CATHETER WAS REPLACED. THE PT RETURNED TO THEIR ROOM. LATER IN THE EVENING THE PT WAS DISCHARGED. PT WAS GETTING DRESSED, WITH THE ASSISTANCE OF THEIR FAMILY MEMBER, AND FAINTED AND FELL. THE PT BEGAN BLEEDING FROM THE CATHETER ON THEIR LEFT SUBCLAVIAN. THE RIGHT ONE, WHICH HAD JUST BEEN REPALCED, WAS INTACT. THE PT BECAME UNRESPONSIVE. A CODE WAS CALLED. THE PT SUFFERED A BLOOD LOSS OF ABOUT 100 TO 200CC. THE PT WAS ADMITTED TO THE INTENSIVE CARE UNIT WITH A QUESTIONABLE AIR EMBOLUS. THE PT REMAINED COMATOSE AND UNRESPONSIVE. IN 06/2001, A DO NOT RESUSCITATE ORDER WAS PLACED AND THEY WERE TRANSFERRED TO HOSPICE CARE. THE PT EXPIRED 6 DAYS LATER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    33022 * LONG TERM DUAL LUMEN DIALYSIS CATHETER LFJ SMITHS INDUSTRIES MEDICAL SYSTEMS, SIMS DELTEC INC UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Hospitalization