BEUDAMED
    FDA Adverse Event Death Summary report: N

    PERMA-CATH

    MDR report key: 268492 · Received March 10, 2000

    Report

    Report Number
    268492
    Event Type
    Death
    Date Received
    March 10, 2000
    Date of Event
    March 4, 2000
    Report Date
    March 10, 2000
    Manufacturer
    NA
    Product Code
    LFJ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    OH, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PT FOUND WITHOUT RESPIRATIONS OR PULSES, IN A POOL OF BLOOD AT 7:20 AM, LYING ON ABDOMEN, DRAPED OVER BASE OF BEDSIDE TABLE ON FLOOR. THE CHEST WALL PERMA-CATH WAS NOT INTACT. THE RED PORT LUMEN WAS SEPARATED APPROX. 1/2" FROM SKIN SURFACE. THE REMAINDER OF CATHETER WAS STILL SUTURED IN THE CHEST WALL. THE SEPARATED PORTION OF CATHETER WITH RED TOP WAS FOUND ON FLOOR. IT IS UNKNOWN HOW THE CATHETER SEPARATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PERMA-CATH CATHETER USED FOR DIALYSIS (BLOOD ACCESS) LFJ NA NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Death DIALYSIS 03/03/2000.